MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II PA SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48041311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; one tip of the screwdriver broke off while inserting screw.Used back up screwdriver.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The driver was inspected and it was found that the tip was fractured.No relevant manufacturing issues were identified as all units met stryker specifications.The most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported that; one tip of the screwdriver broke off while inserting screw.Used back up screwdriver.

• Brand Name: XIA II PA SCREWDRIVER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6370579
• Report Number: 0009617544-2017-00064
• Device Sequence Number: 552679
• Product Code: LXH
• UDI-Device Identifier: 07613327263176
• UDI-Public: (01)07613327263176
• Combination Product (Y/N): N
• 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): 05/15/2017

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: 48041311
• Device Lot Number: 086909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1