MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR QUICK TURN SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48770820
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; aviator screwdriver tip broke.We noticed it after the case.Update 11/2/2016: sales rep indicated "the tip of the screw driver broke as we were using it".
Additional Manufacturer Narrative
Method: risk assessment; result: manufacturing files were not reviewed because the lot number and/or parts were not provided.Conclusion: the probable root cause of the tip material wear is the usage of the instrument.
Event or Problem Description
It was reported that; aviator screwdriver tip broke.We noticed it after the case.Update 11/2/2016: sales rep indicated "the tip of the screw driver broke as we were using it.".

• Brand Name: AVIATOR QUICK TURN SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6080638
• Report Number: 0009617544-2016-00443
• Device Sequence Number: 10915353
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: (01)07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 48770820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR