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

Model Number	48906075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While performing final tightening, the 3.5 hex socket broke off.The procedure was successfully completed with a backup attachment.There were no adverse health consequences.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection.The device was confirmed to have fractured tip.The fractured piece was not returned.The event resulted in no know patient harm.According to the rep, not all pieces retrieved, small piece was stuck in the connector.However no adverse consequences to the patient were reported.A manufacturing review found no relevant manufacturing issues as all units met specifications.Device was manufactured in 2012, making it over 5 years old at the time of the event.The root cause is likely wear of the instrument due to its extended use along with over-torqueing during final tightening and not properly seating the hex within the set screw.The ifu states that "the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.".
Event or Problem Description
While performing final tightening, the 3.5 hex socket broke off.The procedure was successfully completed with a backup attachment.There were no adverse health consequences.

• 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: 7259579
• Report Number: 0009617544-2018-00041
• Device Sequence Number: 13816827
• 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): 04/13/2018

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: Health Professional
• Device Model Number: 48906075
• Device Catalogue Number: 48906075
• Device Lot Number: 124807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1