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 Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the torque wrench broke off inside the patient while tightening of the blocker into rod.A very audible noise was heard when it broke off.The surgeon used needle driver to recover the fragment piece that broke inside the patient.A surgical delay of 10 min was reported.A surgery was completed using backup torque wrench.No adverse consequence to the patient was reported.
Event or Problem Description
It was reported that the torque wrench broke off inside the patient while tightening of the blocker into rod.A very audible noise was heard when it broke off.The surgeon used needle driver to recover the fragment piece that broke inside the patient.A surgical delay of 10 min was reported.A surgery was completed using backup torque wrench.No adverse consequence to the patient was 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 was confirmed via visual inspection.The fractured piece was not returned.The fractured occurred at the hex tip, not at the pin.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A capa investigation found 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.This device was manufactured before the implemented design change.Conclusion: the likely root cause of the reported event is device design and wear due to the device's extended used.

• 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: 8262558
• Report Number: 0009617544-2019-00007
• Device Sequence Number: 13984939
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: 07613327265514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 04/08/2019

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: 111075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 185