MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II UNIVERSAL TIGHTENER 5MM; TEMPLATE FOR CLINICAL USE.

Catalog Number	03807008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon used a torque wrench and a tightener for final tightening of a blocker.The tip of the tightener was broken.The surgeon could not remove the fragment of the tightener from the blocker.The surgeon tried to tighten up the blocker by a counter using two devices.
Additional Manufacturer Narrative
Lot# k419497.Method: visual analysis, device history review, complaint history review, risk assesment.Result: no relevant manufacturing issues were identified during dhr review.The device was confirmed to be fractured upon inspection.Review of the dhr confirms that the device was over 15 years old at the time of fracture.Conclusion: the most likely cause of the reported tip is wear of the device due to prolonged use.
Event or Problem Description
It was reported that during the surgery, the surgeon used a torque wrench and a tightener for final tightening of a blocker.The tip of the tightener was broken.The surgeon could not remove the fragment of the tightener from the blocker.The surgeon tried to tighten up the blocker by a counter using two devices.

• Brand Name: XIA II UNIVERSAL TIGHTENER 5MM
• Common Device Name: TEMPLATE FOR CLINICAL USE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5484956
• Report Number: 0009617544-2016-00100
• Device Sequence Number: 698203
• Product Code: HWT
• UDI-Device Identifier: 07613327262452
• UDI-Public: 07613327262452
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: K419497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1