FDA 483 - Stryker Craniomaxillofacial Division - December 10, 2008

The FDA Form 483 observation identifies a deficiency in complaint handling procedures at Stryker Osteosynthesis. The facility has not implemented procedures to ensure all complaints are processed uniformly and timely.

Specifically, a review of Product Experience Reports (PERs) revealed several instances lacking complete investigation documentation or deviating from Stryker Osteosynthesis's investigation procedure. Status reports for these cases were unavailable as of December 9, 2008.

Examples provided include: a) PER for 10g BoneSource Classic (catalog no. 7941910, lot no. unknown), received August 7, 2008, entered August 13, 2008. Complaint involved an infection, and an MDR was submitted. Released for investigation August 13, 2008. b) PER for Extra Large Custom Cranial Implant (catalog no. 5400104, lot no. 0520812918), received September 15, 2008, entered October 13, 2008. Complaint involved an infection and revision surgery, and an MDR was submitted. Released for investigation October 13, 2008. c) PER for Cannulated Screwdriver Blade (catalog no. 07-40220, lot no. unknown), received and entered October 7,