MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE T HANDLE; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48061000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during a lateral case, two separate trial/shaver handles broke, half the quick release mechanism fell onto the field.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; the customer reported event was confirmed via visual inspection.The tip of the inner sleeve of the t-handle was confirmed to be fractured.No other visual anomalies were observed.Manufacturing history was reviewed and no issues were identified.A root cause of the event was determined to be normal wear and tear and applying excessive load by the user.
Event or Problem Description
It was reported that; during a lateral case, two separate trial/shaver handles broke, half the quick release mechanism fell onto the field.

• Brand Name: RELIANCE T HANDLE
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7050037
• Report Number: 0009617544-2017-00417
• Device Sequence Number: 16493615
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/22/2018

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 Model Number: 48061000
• Device Catalogue Number: 48061000
• Device Lot Number: 14H315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1