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

Model Number 48921002

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6567272
• MDR Text Key: 75321162
• Report Number: 0009617544-2017-00200
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613252662952
• UDI-Public: (01)07613252662952(11)140904(10)144679
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1