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

Catalog Number	48237028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the tip of the screwdriver broke off using the t-handle final tightening torque wrench.The broken fragment was recovered from the patient incision and the surgery was completed with a blocker inserter.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection, product history review, complaint history review, nc/capa history review, risk assessment.The customer reported event was confirmed via visual inspection.The device was confirmed to have the tip fractured off.The fractured piece was not returned.The device had a welded pin at the tip.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Capa was initiated in order to investigate the cause and propose corrective and preventive actions for hex-tip breakages on the device.The capa determined that the breakage of the instrument hex-tip was linked to the insertion and welding of a small pin into the inner shaft.This pin was removed as part of the design change within capa.The device was 8 years old at the time of the event and reported to be used thousands of times.The likely root cause of the reported event is device design and wear due to the device's extended used.
Event or Problem Description
It was reported that the tip of the screwdriver broke off using the t-handle final tightening torque wrench.The broken fragment was recovered from the patient incision and the surgery was completed with a blocker inserter.There are no reports of adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7931886
• Report Number: 0009617544-2018-00237
• Device Sequence Number: 1301732
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: 07613327265514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 11/26/2018

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 Catalogue Number: 48237028
• Device Lot Number: 09C727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1