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

Model Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; on the specified date, (b)(6) 2017, the system was being used in a 2 level alif procedure.One cage had already been implanted at the 5/1 level.The second cage was being implanted at the 4/5 level, and the instrument "inserter guide inner shaft broke at the junction of the finger tightening cylinder and the draw rod that inserts into the cage inserter/guide, during malleting in of the cage into the disk space.There was a second instrument, in the instrument tray, and that was used to complete the insertion of the cage.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence and visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The potential root cause is normal wear and tear.
Event or Problem Description
It was reported that; on the specified date, (b)(6) 2017, the system was being used in a 2 level alif procedure.One cage had already been implanted at the 5/1 level.The second cage was being implanted at the 4/5 level, and the instrument "inserter guide inner shaft broke at the junction of the finger tightening cylinder and the draw rod that inserts into the cage inserter/guide, during malleting in of the cage into the disk space.There was a second instrument, in the instrument tray, and that was used to complete the insertion of the cage.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7206278
• Report Number: 0009617544-2018-00017
• Device Sequence Number: 122608
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: (01)07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 48921100
• Device Catalogue Number: 48921100
• Device Lot Number: 32160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1