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

Catalog Number	48360200
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	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the osteotomy straight chisel bowed at the end and broke partially.Update: per email correspondence attached, "no additional surgery, surgeon was able to retrieve the broken piece with tweezers.".
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant issues were identified in the manufacturing records.Fractured tip was confirmed upon visual inspection.: it is likely that due to the patient¿s hard bone, too much impact force was applied which resulted the breakage of the osteotome tip.
Event or Problem Description
It was reported that the osteotomy straight chisel bowed at the end and broke partially.Update: per email correspondence attached, "no additional surgery, surgeon was able to retrieve the broken piece with tweezers.".

• Brand Name: RELIANCE OSTEOTOME STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6099405
• Report Number: 0009617544-2016-00448
• Device Sequence Number: 695300
• Product Code: LXH
• UDI-Device Identifier: 07613327268362
• UDI-Public: (01)07613327268362
• 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): 01/17/2017

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: 48360200
• Device Lot Number: 160834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR