MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE OSTEOTOME CURVED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48360210
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon used chisel to cut the facet joint! the cutting edge came out deformed.The facet joint was cut and taken out with another chisel that the hospital owned.No deformity of the second chisel.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.Tip of the device was confirmed to be deformed.No material or manufacturing defects were found.A root cause of the event is too much impaction force applied to the instrument leading to deformation.
Event or Problem Description
It was reported that; surgeon used chisel to cut the facet joint! the cutting edge came out deformed.The facet joint was cut and taken out with another chisel that the hospital owned.No deformity of the second chisel.

• Brand Name: RELIANCE OSTEOTOME CURVED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6870020
• Report Number: 0009617544-2017-00359
• Device Sequence Number: 11094043
• Product Code: LXH
• UDI-Device Identifier: 07613327268379
• UDI-Public: (01)07613327268379
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 11/30/2017

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: 48360210
• Device Lot Number: 169139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80