MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC MINIMAL ACCESS DRIVER,ANGLED; DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT

Catalog Number MA-D20-G1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure of the spine, it was observed that the minimal access attachment device was not turning the cutter device.There were no delays in the surgical procedure as an identical spare device was used to complete the procedure successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the device was not turning the drill bit device was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device failed cutter insertion.It was determined that the bearings were worn out and loose creating a situation where the cutter was not able to be inserted.It was determined that this was because the bearings were no longer in axial alignment not allowing the cutter to pass through.It was determined that this failure was due to worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: MINIMAL ACCESS DRIVER,ANGLED
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7392858
• MDR Text Key: 104419605
• Report Number: 1045834-2018-50685
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384016397
• UDI-Public: (01)845384016397(11)160622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA-D20-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1