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

Model Number	48061000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reliance t-handle is having trouble releasing shafts outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
A visual inspection performed found the device laser markings are worn.The functional inspection performed confirmed the reported event whereby the reliance t-handle was having trouble releasing shafts pre-op.Functionally, it was not possible to attach handle to driver/shaver.The locking mechanism could not close on proximal end of associated device and rattling was heard inside handle.Device history records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in march 2012 and is over 9 years old.Complaint history record review was performed for this lot and catalog number and no adverse trends were identified.The most likely cause of the reported event was determined to be due to devices age and normal wear.
Event or Problem Description
It was reported that a reliance t-handle is having trouble releasing shafts outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• 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: 13697286
• Report Number: 0009617544-2022-00028
• Device Sequence Number: 20423825
• 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): 06/03/2022

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: 122368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2012
• 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