MAUDE Adverse Event Report: STRYKER SPINE-US RELIANCE T HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48061000
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reliance t-handle was jamming outside the operating room.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.
Additional Manufacturer Narrative
The device was visually inspected, one of the two prongs of the locking mechanism on the handle is fractured off.The fractured piece was not returned.Device history records were reviewed for this lot, no relevant manufacturing issues were identiifed.The device was manufactured in 2010, over 11 years ago.Complaint history records were reviewed for this catalog number, no adverse trends were identiifed.It was reported via follow up communication that the handle would not completely attach to the shafts.The device ifu was reviewed: for instruments designed for re-use: - 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.- instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.The most likely cause of the reported event was determined to be due to the age of the device and normal use over time.Device is over 11 years old.
Event or Problem Description
It was reported that a reliance t-handle was jamming outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.

• Brand Name: RELIANCE T HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14566795
• Report Number: 0009617544-2022-00059
• Device Sequence Number: 5723163
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: 07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/23/2022

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: 48061000
• Device Catalogue Number: 48061000
• Device Lot Number: 109339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown