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

Catalog Number	IS2640BPL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; inserted jammed then broke.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: according to the general instruments ifu, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.The manufacturing history review revealed that the device was more than 4 years old at the time.It was reported that the inserter was stuck/jammed and then the surgeon had to hammer it to get it loose, which resulted that breakage.The age of the device may have resulted the device to get jammed or loose its proper functionality.Due to which the surgeon had to hammer the instrument that resulted the tip of the instrument to get fractured off.Conclusion: therefore the possible root causes of the reported event are: normal material wear and tear of the instruments and excessive force applied.
Event or Problem Description
It was reported that; inserted jammed then broke.

• 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: 5680258
• Report Number: 3004024955-2016-00056
• Device Sequence Number: 166502
• Product Code: LXH
• UDI-Device Identifier: 07613327141979
• UDI-Public: (01)07613327141979
• Combination Product (Y/N): N
• 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): 04/29/2016

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: 05/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1