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	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Torque wrench broke during final tightening of blockers.Broken parts were taken out by surgeons with osteotome.
Event or Problem Description
Torque wrench broke during final tightening of blockers.Broken parts were taken out by surgeons with osteotome.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The torque wrench tip was confirmed to be fractured.All broken fragments were retrieved.The fractured piece was not returned.Capa was initiated to investigate the recurrent issue of hex-tip breakage.The main cause of the breakage was determined to be the incorrect heat treatment of the torsion shaft material which resulted in embrittlement.Other contributing factors were also identified during the root-cause analysis that include poor manufacturing (machining lines) leads to a weaker hex-tip: machining lines create stress concentration areas, design geometry causes stress concentration: insufficient fillet at the radius between the hex and the main cylinder leads to increased stress concentration, user-error: the surgeon applies excessive torque and/or cantilever during final tightening.This specific lot, was recalled and hong kong was notified of this recall and confirmed that they received the notification on (b)(6) 2013 and executed appropriately.Conclusion: the root cause is incorrect heat treatment of the torsion shaft material which resulted in embrittlement.

• 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: 7812569
• Report Number: 0009617544-2018-00204
• Device Sequence Number: 14075777
• Product Code: LXH
• UDI-Device Identifier: 07613327265514
• UDI-Public: 07613327265514
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• 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: 11E043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/24/2018
• 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