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

Catalog Number	03807028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the instrument broke off during surgery.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event of a was confirmed via visual inspection.The tip of the instrument was confirmed to be fractured off.The fracture did not occur at the pin.The fractured piece was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was found to be manufactured in 2006.Conclusion: it is most likely that the tip fractured due to wear as this device was over 12 years old at the time of the event.
Event or Problem Description
It was reported that the tip of the instrument broke off during surgery.No adverse consequences to the patient is reported.

• 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: 7831430
• Report Number: 0009617544-2018-00212
• Device Sequence Number: 2446664
• Product Code: LXH
• UDI-Device Identifier: 07613327262292
• UDI-Public: 07613327262292
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/19/2018

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: 03807028
• Device Lot Number: 060073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1