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

Catalog Number	48906075
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hex attachment for the torque driver broke while torquing the connectors, had another hex attachment that was used successfully.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all released units met stryker specifications.The event happened during final tightening.The device was determined to be 12 years old at the time of the event, and the customer was unable to estimate how many times it was used before.Conclusion: the most likely cause of the event was failure during torquing due to wear caused by the device's extended use.
Event or Problem Description
It was reported that the hex attachment for the torque driver broke while torquing the connectors, had another hex attachment that was used successfully.

• Brand Name: TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH
• Common Device Name: ORTHOPEDICS MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5679620
• Report Number: 0009617544-2016-00205
• Device Sequence Number: 213190
• Product Code: LXH
• UDI-Device Identifier: 07613327273328
• UDI-Public: (01)07613327273328
• Combination Product (Y/N): N
• 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): 05/06/2016

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: 045186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1