MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II UNIVERSAL TIGHTENER 5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03807008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; blocker insert's tip was broken during the surgery at hospital.The surgery was completed successfully with spare blocker inserter.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: no relevant manufacturing issues were identified during dhr review.The device was confirmed to be fractured upon inspection.Conclusion: the most likely cause of the reported tip fracture is an overload due to over-torquing of the device.
Event or Problem Description
It was reported that; blocker insert's tip was broken during the surgery at hospital.The surgery was completed successfully with spare blocker inserter.

• Brand Name: XIA II UNIVERSAL TIGHTENER 5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6035027
• Report Number: 0009617544-2016-00418
• Device Sequence Number: 77803
• Product Code: LXH
• UDI-Device Identifier: 07613327262452
• UDI-Public: (01)07613327262452
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: 03807008
• Device Lot Number: 14E394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1