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

Catalog Number	482391312S
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the driver and tap damaged during case.
Additional Manufacturer Narrative
The investigation is pending due to the return of the device.Additional supplemental will be completed upon closure of the investigation.
Event or Problem Description
It was reported that the driver and tap damaged during case.
Additional Manufacturer Narrative
Method: visual inspection;device history review; complaint history review; risk assessment; results: the device was inspected and it was found that one of the tip prongs was fractured off.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported that the driver and tap damaged during case.

• Brand Name: XIA II POLYAXIAL SCREWDRIVER SHAFT SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6059098
• Report Number: 0009617544-2016-00425
• Device Sequence Number: 863859
• Product Code: LXH
• UDI-Device Identifier: 07613327276732
• UDI-Public: (01)07613327276732
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2017

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: 482391312S
• Device Lot Number: 109577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 01/17/2017; 02/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1