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 Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that torque wrench fractured at the distal tip when final tightening a blocker , during an anterior release with scoliosis correction procedure carried out at the l2 level.The distal tip of the torque wrench became loosened from the blocker and remains implanted in the patient.The surgeon does not see a need to remove it and is not concerned.Blocker was assumed to be final tightened.Another final torque was used to final tighten the remaining blockers so the surgery could be completed.No adverse consequences to the patient.
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 torque wrench was confirmed to have the tip fractured off.The fractured piece was not returned.The torque wrench also had a welded pin at the tip.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Result: capa was initiated in order to investigate the cause and propose corrective and preventive actions for hex-tip breakages on torque wrenches.A detailed investigation performed for capa showed that the breakage of the instrument hex-tip was linked to the insertion and welding of a small pin into the inner shaft.The small pin that was inserted into the inner and outer shaft was used to ensure a strong connection between the two shafts.This pin was removed as part of the design change within capa.Additionally, this device was 7 years old at the time of the event, so wear due to the device's extended use also likely contributed to the event.
Event or Problem Description
It was reported that torque wrench fractured at the distal tip when final tightening a blocker , during an anterior release with scoliosis correction procedure carried out at the l2 level.The distal tip of the torque wrench became loosened from the blocker and remains implanted in the patient.The surgeon does not see a need to remove it and is not concerned.Blocker was assumed to be final tightened.Another final torque was used to final tighten the remaining blockers so the surgery could be completed.No 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: 7918088
• Report Number: 0009617544-2018-00234
• Device Sequence Number: 19400518
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: 07613327265514
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 11/20/2018

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: 48237028
• Device Lot Number: 111076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1