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

Catalog Number	48360200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device chipped intra-op.No adverse consequence to the patient was reported.The surgery was completed successfully without any delay.
Event or Problem Description
It was reported that the device chipped intra-op.No adverse consequence to the patient was reported.The surgery was completed successfully without any delay.
Additional Manufacturer Narrative
Lot # information added and product availability field updated as the device was returned.The reported event was confirmed via visual inspection.The device was inspected, and the tip of the device was confirmed to be deformed; the tip of the device was bent and no longer a straight edge.Manufacturing history review was performed no manufacturing related issue was found.It was reported that the device was being impacted when the issue occurred.Patient had hard bone quality.The plausible root cause is patient's hard bone quality which required excessive impaction force for bone removal.

• Brand Name: RELIANCE OSTEOTOME STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8061339
• Report Number: 0009617544-2018-00263
• Device Sequence Number: 1593953
• Product Code: LXH
• UDI-Device Identifier: 07613327268362
• UDI-Public: 07613327268362
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 48360200
• Device Lot Number: 180610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1