MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48906075
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; torque wrench tip broke while final tightening.Tip was then stuck in connector and had to burr it out.
Additional Manufacturer Narrative
Lot # 12c457.Method: visual inspection; device history review; complaint history review; risk assessment.Results: the device was examined and confirmed to be fractured at the tip.Additionally, it was confirmed that the device was over 3 years old.Conclusion: the most likely cause of this event is wear of the device as a result of its use for an extended period of time.
Event or Problem Description
It was reported that; torque wrench tip broke while final tightening.Tip was then stuck in connector and had to burr it out.

• Brand Name: TRIO CONNECTOR 3.5 MM HEX SOCKET FOR 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: 5648149
• Report Number: 0009617544-2016-00182
• Device Sequence Number: 308559
• Product Code: LXH
• UDI-Device Identifier: 07613327273328
• UDI-Public: (01)07613327273328
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 03/09/2016

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: 48906075
• Device Lot Number: 12C457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2016
• Supplement Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1