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

Catalog Number	48237028
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the torque wrench broke during final tightening.
Additional Manufacturer Narrative
Method: visual inspection;device history review; complaint history review; risk assessment; results: the hex-tip on the returned instrument was confirmed to be broken.Conclusion: the main cause of the breakage was determined to be the incorrect heat treatment of the torsion shaft material which resulted in embrittlement.
Event or Problem Description
It was reported that the torque wrench broke during final tightening.

• 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: 5551836
• Report Number: 0009617544-2016-00140
• Device Sequence Number: 562454
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: (01)07613327265514
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2016

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: 48237028
• Device Lot Number: 093655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1