MAUDE Adverse Event Report: STRYKER SPINE-US XIA II TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03807028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the xia ll torque wrench to lock the nut, the tip of the device fractured.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection confirms that the tip of the torque wrench has fractured off.Fracture did not occur at the pin.The fractured piece was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is most likely that the tip fractured due to wear as this device was over 15 years old at the time of the event.
Event or Problem Description
It was reported that while using the xia ll torque wrench to lock the nut, the tip of the device fractured.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully by using an alternatively available instrument.

• Brand Name: XIA II TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12026116
• Report Number: 0009617544-2021-00107
• Device Sequence Number: 19648306
• Product Code: LXH
• UDI-Device Identifier: 07613327262292
• UDI-Public: 07613327262292
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 10/25/2021

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: Health Professional
• Device Model Number: 03807028
• Device Catalogue Number: 03807028
• Device Lot Number: 057978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1