MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL PILOT CUTTER; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48921002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while using the pilot cutter, the surgeon cut the channel and while back slapping the device out, the pressed fit back slap mechanism on the pilot cutter flew off onto the floor.Surgeon did not use a lot a force and it came off, leaving the pilot cutter stuck in the patient.Vice grips were applied back slap hammer was utilized and pilot cutter was removed.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via the received image and visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be related: (1) normal wear due to long time usage; (2) impaction overloading.
Event or Problem Description
It was reported that; while using the pilot cutter, the surgeon cut the channel and while back slapping the device out, the pressed fit back slap mechanism on the pilot cutter flew off onto the floor.Surgeon did not use a lot a force and it came off, leaving the pilot cutter stuck in the patient.Vice grips were applied back slap hammer was utilized and pilot cutter was removed.There were no adverse consequences to the patient.

• Brand Name: AERO AL PILOT CUTTER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6567272
• Report Number: 0009617544-2017-00200
• Device Sequence Number: 16309238
• Product Code: OVD
• UDI-Device Identifier: 07613252662952
• UDI-Public: (01)07613252662952(11)140904(10)144679
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/25/2017

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 Model Number: 48921002
• Device Catalogue Number: 48921002
• Device Lot Number: 144679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1