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

Catalog 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	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hex socket broke during final tightening.All broken fragments were retrieved and the procedure was completed with an alternate instrument, with no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, risk assessment result: the customer reported event was confirmed via visual inspection.The device was inspected and confirmed to have a fractured tip.It appears all fractured pieces were returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.According to capa, root cause was identified to be use error relating to over-torqueing during final tightening and not properly seating the hex within the set screw.Additionally, the device was over 3 years old.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." conclusion: the root cause is likely wear of the instrument due to its extended use along with possible over-torqueing and/or improper seating during final tightening.
Event or Problem Description
It was reported that the hex socket broke during final tightening.All broken fragments were retrieved and the procedure was completed with an alternate instrument, with no adverse consequences to the patient.

• Brand Name: TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7847928
• Report Number: 0009617544-2018-00214
• Device Sequence Number: 1966867
• Product Code: LXH
• UDI-Device Identifier: 07613327273328
• UDI-Public: 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): 11/26/2018

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: 48906075
• Device Lot Number: 14A758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1