MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283729

Device Problems Peeled/Delaminated (1454); Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).(b)(4).

Event Description

It was reported by the affiliate via e-mail that during an arthroscopic shoulder stabilization small metal shards observed following activation of ultra aggressive plus blade.Blade was being used to excise labral tissue in oscillate mode.Settings on fms vue1 were 2500rpm oscillation and 100mmhg respectively.Fms used in inflow/outflow mode.Surgeon noted that suction wasn't responding through shaver hand piece.Later in procedure it was noted that the shaver outflow tubing was attached to the rf rather than the shaver.Shards noticed after around 30 seconds of constant activation.Shards observed around glenoid and over labrum.Cleared away by putting shaver directly onto wall suction (joint cleaned by sucking out shards systematically around glenoid space).Delay to surgery of around 5 minutes attributed to investigation time and removal of metal fragments from the joint.Additional information received by the affiliate reported an alternative product was available but not required.The affiliate also reported soft tissue debridement was completed with an rf probe and there were no known adverse effects to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.The device was received for evaluation.Visual inspection under magnification shows that there are some small areas on the distal tip of the device that indicates that it might have come in contact with a hard surface or a bone.The device was reviewed with the r&d quality engineer for the product who agreed that this would be the probable root cause of this failure.Other than this possibility we cannot determine a root cause based on the information provided and the analysis of the product.The reported suction failure in this complaint seems to be a set-up problem and is not related to the device that was returned.This complaint can be confirmed.A manufacturing record evaluation was performed on 7/18/2019 for the finished device lot number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy 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).

Manufacturer Narrative

Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: ULTRA AGGRESSIVE PLUS 5.0 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8862282
• MDR Text Key: 154417736
• Report Number: 1221934-2019-57898
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022083
• UDI-Public: 10886705022083
• 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,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 283729
• Device Lot Number: M1807006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 10/04/2019
• Patient Sequence Number: 1