MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283429

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the affiliate in (b)(4) that during a shoulder arthroscopy procedure on an unknown date, it was observed that there were metal abrasions while using a 4 mm ultra aggressive plus device.Another like device was used to complete the procedure with a delay of five minutes.It was reported that a lavage was made on the shoulder but some parts are still inside the joint of the patient.The status of the patient post-surgery was unknown.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d4, h4: the expiration and manufacture date were reported as unknown on the initial report.Both fields have been updated accordingly.Udi: (b)(4).Investigation summary: according to the information received, it was reported that during a shoulder arthroscopy while using a 4 mm ultra aggressive plus, with the first randoms of the shaverblade the metal abrasion happened.They made a lavage of the shoulder and used other shaverblade.Some parts are still in the joint of the patient, and there was a surgical delay of 5 minutes.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided upon visual inspection of the photo, it appeared to have metal shaving on the tissue.The complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device lot number: m2003021, and no nonconformance were identified.Hands on analysis should provide the evidence necessary to confirm the root cause due to it is important to inspect the inner and outer sleeves for any visual defects that may contribute to the complaint condition.The possible root cause for reported failure can be attributed to blade wear and degradation, as per ifu; excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device.Besides, a hand piece used in this procedure where the blade is assembled was not received for evaluation, potential ways to reduce shedding is to ensure all hand pieces are properly serviced and maintained to assure the presence of the o-ring since the lack/damaged o-ring can contribute to shedding issue.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.

• Brand Name: ULTRA AGGRESSIVE PLUS 4.0MM 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: 11230938
• MDR Text Key: 228927559
• Report Number: 1221934-2021-00243
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M2003021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention