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

Catalog Number	48328500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was implanting the screw and the tip of the screwdriver sheared off in the screw head.Surgeon was unable to retrieve the sheared portion.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assesment; result: the device was not returned for evaluation.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.According to the instructions for use, instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures and disposal attention.Instruments must be examined for wear or damage prior to surgery.Conclusion: due instrument being in use for 5 years the plausible root cause for tip fracture is normal wear and tear.
Event or Problem Description
It was reported that the surgeon was implanting the screw and the tip of the screwdriver sheared off in the screw head.Surgeon was unable to retrieve the sheared portion.

• 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: 5869087
• Report Number: 0009617544-2016-00331
• Device Sequence Number: 13571017
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2016

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: 113837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1