MAUDE Adverse Event Report: DEPUY MITEK 5 MM BARREL TORNADO BUR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283889

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) - incomplete.The expiration date is not currently available.

Event Description

Affiliate reported via email metal debris at acromizer.The procedure was completed with same like product with a two minute delay.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual observation under a microscope showed clear evidence of heavy usage on the inner burr and the inner cutting window.Nicks and marks were observed on the inner tip and it appeared to be chipped on one side.The tip of the outer shaft also looked nicked and worn.The shiny part seen on the distal tip of the outer shaft indicates that there were some metal shavings from that part of the device.This type of failure is consistent with the device hitting hard bone causing the wear at the distal tip on the inner blade.Application of too much pressure against the bone might have caused the metal at the distal end of the device to shave/chip.Also, since there was burr observed on the inner shaft, the friction between inner and the outer shaft might have caused some part of the metal debris from the inner shaft to fall into the patient.However, apart from these possibilities, we cannot determine a definite root cause for this failure at this point in time.Further, a review of the device history record for the reported batch number revealed no anomalies relating to the reported incident.A non-conformance was opened for this lot.However, it was not related to the issue reported in this complaint.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Event Description

Affiliate reported via email metal debris at (b)(6).The procedure was completed with same like product with a two minute delay.Additional information was obtained via e-mail from the affiliate on 11-17-2017: the incident occured during procedure.The fragments were flushed out.There were no patient anatomy factors or procedural factors that might have contributed to the event.No surgical intervention is planned.No particulates/ shavings remain in the patient.No patient impact.

• Brand Name: 5 MM BARREL TORNADO BUR PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7030077
• MDR Text Key: 92767509
• Report Number: 1221934-2017-10666
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017,11/17/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 283889
• Device Lot Number: M1705021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1