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

Catalog Number	48328550
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the screwdriver fractured when inserted the screw.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The device was not returned, therefore, visual inspection and functional inspection could not be performed.The plausible root cause of the reported event cannot be determined conclusively as the instrument was not returned and insufficient information was provided.
Event or Problem Description
It was reported that; the screwdriver fractured when inserted the screw.

• Brand Name: ANCHOR C SCREWDRIVER - FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6482797
• Report Number: 0009617544-2017-00137
• Device Sequence Number: 662526
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 06/22/2017

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: 48328550
• Device Lot Number: 14C906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1