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

Catalog Number	48237028
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	10/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the surgeon used the torque wrench and anti torque key for the final tightening of the blocker.The tip of torque wrench was broken.The surgeon removed the fragment of the torque wrench from the blocker.Therefore the surgeon changed the torque wrench to another torque wrench.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Tip fracture was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause of the event is determined to be normal wear due to extensive use of the device over a period of 8 years.
Event or Problem Description
It was reported that; during surgery, the surgeon used the torque wrench and anti torque key for the final tightening of the blocker.The tip of torque wrench was broken.The surgeon removed the fragment of the torque wrench from the blocker.Therefore the surgeon changed the torque wrench to another torque wrench.

• 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: 6068163
• Report Number: 0009617544-2016-00436
• Device Sequence Number: 747550
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: (01)07613327265514
• 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): 01/12/2017

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: 48237028
• Device Lot Number: 086705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR