MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE AL KERRISON 5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48366205
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument broke.Alternative instrument was used.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment; result: the customer reported event of kerrison disengagement was confirmed via visual and functional inspections.The top section of the assembly was found to be disengaged from the bottom.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be almost 3 years.Conclusion: a root cause of the event is multifactorial.Contributing factors: normal wear and tear, improper handling of the instrument and excessive force applied during use.
Event or Problem Description
It was reported that the instrument broke.Alternative instrument was used.

• Brand Name: RELIANCE AL KERRISON 5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6932438
• Report Number: 0009617544-2017-00373
• Device Sequence Number: 10967417
• Product Code: LXH
• UDI-Device Identifier: 07613327269970
• UDI-Public: (01)07613327269970
• 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): 01/03/2018

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 Model Number: 48366205
• Device Catalogue Number: 48366205
• Device Lot Number: 149043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1