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

Catalog Number	486619085
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the t handle was pulled to connect to a probe shaft in order to remove the shaft from the patient, the t handle broke up.There were no remaining broken fragments in the patient.The surgery was completed with another t handle.There are no adverse consequences to the patient.
Additional Manufacturer Narrative
The customer reported event of was confirmed via visual inspection.The t handle was returned completely disassembled.The spring, locking clip, 2 ball bearings and locking collar were disengaged from the t handle shaft.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The t handle was manufactured in 2008, making it over 10 years old at the time of the event.Capa was opened to address handle disassembly issue.The only way to disassemble the handle is to disengage the locking c-ring from its groove leading to the product disassembly.Cleaning may have play a role on the clip disassembly from its designed groove.A design change was done to reduce incidence of this.Result: the most likely root cause is the locking clip disengaged from the locking collar, causing the handle to disengage in multiple pieces.As the device was over 10 years old, the ring may have worn out causing it to disengage.
Event or Problem Description
It was reported that when the t handle was pulled to connect to a probe shaft in order to remove the shaft from the patient, the t handle broke up.There were no remaining broken fragments in the patient.The surgery was completed with another t handle.There are no adverse consequences to the patient.

• Brand Name: RADIUS PROBE SHAFT T-HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7796610
• Report Number: 0009617544-2018-00198
• Device Sequence Number: 1116674
• Product Code: LXH
• UDI-Device Identifier: 07613327276046
• UDI-Public: 07613327276046
• Combination Product (Y/N): N
• 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): 11/20/2018

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: 486619085
• Device Lot Number: 07H198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1