MAUDE Adverse Event Report: DEPUY MITEK 5.0 MM BARREL BURR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283869

Device Problems Break (1069); Metal Shedding Debris (1804)

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

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the affiliate that there was broken metal swarf into the shoulder joint on several occasions.The joint was cleaned out with suction.There was a five minute delay to the procedure.There was no patient harm.The case could be completed.

Event Description

It was reported by the affiliate that there was broken metal swarf into the shoulder joint on several occasions.The joint was cleaned out with suction.There was a five minute delay to the procedure.There was no patient harm.The case could be completed.The following information was obtained on 3-28-2018: the procedure was completed using alternative device.Alternatives were readily available.No further surgery required.The shaving/particles were flushed out and removed with suction with the best of ability.Product is no longer available to be returned.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A review of the device history record indicated that this batch of product was released through an unrelated non-conformance with no link to the reported issue and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.We cannot discern a root cause for the reported failure mode.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).

• Brand Name: 5.0 MM BARREL BURR PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7338082
• MDR Text Key: 102733729
• Report Number: 1221934-2018-50297
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023080
• UDI-Public: 10886705023080
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 283869
• Device Lot Number: M1707029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1