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

Model Number	48237028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the torque wrench broke apart.The tip could was scrapped by customer.
Additional Manufacturer Narrative
Lot#: 10g715.Visual inspection, device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The hex-tip on the returned instrument was confirmed to be broken.As the event is multifactorial in nature, a specific root cause cannot be determined.
Event or Problem Description
It was reported that the tip of the torque wrench broke apart.The tip could was scrapped by customer.

• 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: 6566704
• Report Number: 0009617544-2017-00198
• Device Sequence Number: 624724
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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 Model Number: 48237028
• Device Catalogue Number: 48237028
• Device Lot Number: 10G715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1