MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328500
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the driver will no longer hold a screw on the end.Dropped a screw into the wound off the tip of the inserter.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the device was approximately 5 years old at the time of the event and the anchor c ifu indicates that instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Conclusion: the plausible root cause is normal material wear.
Event or Problem Description
It was reported that; the driver will no longer hold a screw on the end.Dropped a screw into the wound off the tip of the inserter.

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5492321
• Report Number: 0009617544-2016-00114
• Device Sequence Number: 272455
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48328500
• Device Lot Number: 111872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 05/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1