MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL REVISION GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48921050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the tip broke off inside the implant while they were trying to thread the revision driver inside the implant.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to be fractured upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the most likely cause of the reported event was determined to be overloading in a torsional way while threading the inner shaft.
Event or Problem Description
It was reported that; the tip broke off inside the implant while they were trying to thread the revision driver inside the implant.

• Brand Name: AERO AL REVISION GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5435331
• Report Number: 0009617544-2016-00057
• Device Sequence Number: 302501
• Product Code: LXH
• UDI-Device Identifier: 07613327273472
• UDI-Public: 07613327273472
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2016

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: 48921050
• Device Lot Number: 143461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2016
• Supplement Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1