MAUDE Adverse Event Report: STRYKER SPINE-US 9MM UNILIF BONE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2640BPL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; one of the tines on the bone inserter broke off.The facility had two inserters.They were able to use the second inserter to successfully complete the procedure.
Additional Manufacturer Narrative
Method: visual inspection; device history review, complaint history review; risk assesment result: the device was confirmed to have a fractured tip during visual inspection of the returned device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the plausible root cause of the reported event is a user applied cantilever overload based on materials analysis in addition to due to normal wear and tear of instruments.
Event or Problem Description
It was reported that; one of the tines on the bone inserter broke off.The facility had two inserters.They were able to use the second inserter to successfully complete the procedure.

• Brand Name: 9MM UNILIF BONE INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5730877
• Report Number: 3004024955-2016-00063
• Device Sequence Number: 3508
• Product Code: LXH
• UDI-Device Identifier: 07613327141979
• UDI-Public: (01)07613327141979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2016

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: IS2640BPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1