MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ILIAC SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48231326
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that as surgeon was advancing pedicle screw, too much torque was applied thus screwdriver threads broke.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the event was confirmed via a visual inspection of the returned device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event is user related specifically over-torquing of the device during screw insertion.
Event or Problem Description
It was reported that as surgeon was advancing pedicle screw, too much torque was applied thus screwdriver threads broke.

• Brand Name: XIA 3 TITANIUM ILIAC 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: 6221263
• Report Number: 0009617544-2017-00002
• Device Sequence Number: 921475
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 48231326
• Device Lot Number: 141253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1