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

Catalog Number	48061000
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon impacting the handle, a piece of metal broke off the bottom of t handle.The piece was retrieved immediately.The surgeon then used the slap hammer to remove the trail, still attached to the t handle, and upon i,parting the hammer on the handle, the blue t part of the handle removed, still leaving the trial in place.The slap hammer was reattached to the trial and successfully removed.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The t handle was returned in 2 pieces.The rubber handle portion was fractured from the metal shaft.Additionally, the inner locking collar was fractured as well.The possible root cause of this event is the application of excessive torsional force leads to instrument not able to handle force applied to insert in disc space leading to cleavage and ductile overload leading to fracture of the instrument.
Event or Problem Description
It was reported that; upon impacting the handle, a piece of metal broke off the bottom of t handle.The piece was retrieved immediately.The surgeon then used the slap hammer to remove the trail, still attached to the t handle, and upon i,parting the hammer on the handle, the blue t part of the handle removed, still leaving the trial in place.The slap hammer was reattached to the trial and successfully removed.

• Brand Name: RELIANCE T HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6498756
• Report Number: 0009617544-2017-00151
• Device Sequence Number: 1048700
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 48061000
• Device Lot Number: 131689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR