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

Model Number	03807028
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner shaft of the torque wrench broke during the final tightening of pedicle screws at the l4-l5 level.There was a reported delay of more than 20 minutes.The surgery was successfully completed with an alternate torque wrench.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event of was confirmed via correspondence with the representative.The device was not returned and thus inspection of it could not be performed.The reported lot number was invalid and a manufacturing record review could not be performed.As the manufacturing date is unknown, the age of the device cannot be determined, but it was reported that the device was used 74 times.The instruments ifu states that "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".As the device was not returned for evaluation and the lot number reported was invalid, a root cause cannot be determined.
Event or Problem Description
It was reported that the inner shaft of the torque wrench broke during the final tightening of pedicle screws at the l4-l5 level.There was a reported delay of more than 20 minutes.The surgery was successfully completed with an alternate torque wrench.There are no reports of adverse health consequences.

• Brand Name: XIA II 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: 7249952
• Report Number: 0009617544-2018-00040
• Device Sequence Number: 13719853
• Product Code: LXH
• UDI-Device Identifier: 07613327262292
• UDI-Public: (01)07613327262292
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/26/2018

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: Health Professional
• Device Model Number: 03807028
• Device Catalogue Number: 03807028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1