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

Catalog Number	48360200
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: instrument broke during the lumbar arthrodesis procedure.The surgeon used another instrument that was in the box.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: upon device history review, device was found to be more than 3 years old.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the plausible root cause of this reported event is normal wear and tear of instruments.
Event or Problem Description
It was reported that; instrument broke during the lumbar arthrodesis procedure.The surgeon used another instrument that was in the box.

• 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: 5994936
• Report Number: 0009617544-2016-00394
• Device Sequence Number: 698539
• Product Code: LXH
• UDI-Device Identifier: 07613327268362
• UDI-Public: (01)07613327268362
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

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: 122286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1