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

Catalog Number	48237028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was final torquing the blockers and the final torque broke.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assesment.Manufacturing records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.Inspection of the device confirmed it was fractured at the shaft.The material analysis determined that the device fractured in fatigue.It was confirmed that the device was manufactured in 2009 and is over 7 years old.The most likely cause of the customer reported event is normal wear due to extended use of the device, resulting in an eventual fatigue fracture.
Event or Problem Description
It was reported that the surgeon was final torquing the blockers and the final torque broke.

• Brand Name: XIA 3 TITANIUM TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5585661
• Report Number: 0009617544-2016-00155
• Device Sequence Number: 21374
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: (01)07613327265514
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2016

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: 48237028
• Device Lot Number: 093654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2016
• Supplement Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1