MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM TORQUE WRENCH SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	482397028
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a xia 3 titanium torque wrench short tip fractured during final tightening.The fractured piece was successfully removed for the patient.
Additional Manufacturer Narrative
Visual inspection: it was confirmed that the tip of the torque wrench was fractured.The fractured piece was not returned.The torque wrench has the tip pin present.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From the instruments ifu: incorrect maintenance, cleaning or handling may render the instruments unsuitable for their intended use, cause corrosion, dismantling, distortion and/or breakage or cause injury to the patient or operating staff.The life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.The xia 3 surgical technique provides instructions on the use of the xia 3 titanium torque wrench: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; ,standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.The device is over 9 years old and wear from the device's extended use most likely contributed to the event.
Event or Problem Description
It was reported that a xia 3 titanium torque wrench short tip fractured during final tightening.The fractured piece was successfully removed for the patient.

• Brand Name: XIA 3 TITANIUM TORQUE WRENCH SHORT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9482686
• Report Number: 0009617544-2019-00143
• Device Sequence Number: 13527188
• Product Code: LXH
• UDI-Device Identifier: 07613327275711
• UDI-Public: 07613327275711
• Combination Product (Y/N): N
• PMA/510(K) Number: K172034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 482397028
• Device Catalogue Number: 482397028
• Device Lot Number: 10C067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1