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

Catalog Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon insertion of a trial, inserter inside shaft and trial broke.Additional note: two of blades did not go into the cage and are imbedded in the bone due to the inserter insde shaft breaking.
Additional Manufacturer Narrative
Lot# 143459; visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual analysis.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the reported event is due to the overload of applied cantilever force.
Event or Problem Description
It was reported that upon insertion of a trial, inserter inside shaft and trial broke.Additional note: two of blades did not go into the cage and are imbedded in the bone due to the inserter inside shaft breaking.

• Brand Name: AERO AL INSERTER 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: 5995384
• Report Number: 0009617544-2016-00397
• Device Sequence Number: 1916990
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: (01)07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/06/2017

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: 48921100
• Device Lot Number: 143459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1