MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL TRIAL,22X28MM,11MM, 8DEG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48928122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon insertion of the trial the inserter, 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.
Additional Manufacturer Narrative
Lot# 144718; visual inspection.Since the reported event is on the tip of the handle fractured and stuck inside this reported trial, the trial was determined to be a concomitant product.Since the reported event is on the tip of the handle fractured and stuck inside this reported trial, the trial was determined to be a concomitant product.
Event or Problem Description
It was reported that; upon insertion of the trial the inserter, 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 TRIAL,22X28MM,11MM, 8DEG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5999337
• Report Number: 0009617544-2016-00399
• Device Sequence Number: 10988561
• Product Code: LXH
• UDI-Device Identifier: 07613327273618
• UDI-Public: (01)07613327273618
• 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: 48928122
• Device Lot Number: 144718
• 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: 10/05/2016
• 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