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

Model Number	283719
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up medwatch will be filed as appropriate.Udi: (b)(4)incomplete.The lot number was unknown.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 or Problem Description
It was reported by the affiliate in austria that during a shoulder repair procedure on (b)(6) 2020, it was observed that there were a lot of metal abrasions during a 10,000 forward with the handpiece device.There was a delay of five minutes in the procedure.Another like device was used to complete the procedure.The fragments were removed easily.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: 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.Additional information: lot number (d4): it was reported by the affiliate that the lot number of the device is m1911049.Udi: (b)(4).
Additional 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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.D4, h4: the expiration and manufacture dates were reported as unknown on the initial report.Both fields have been updated accordingly.Therefore, udi: (b)(4).Investigation summary: according to the information provided, it was reported that during a lot of metal abrasion during 10.000 forward with tornado handpiece.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.The complaint device was received and evaluated.The inner and outer sleeves were separated and inspected for any visual defects that may contribute to the complaint condition.The device had signs of friction and striation marks of wear on the surface of the distal end of the inner blade and inside the outer.A manufacturing record evaluation was performed for the finished device lot number:m1911049, and no nonconformances were identified.Based on device condition received, this complaint can be confirmed.Besides, as per information provided in this procedure, the possible root cause for reported failure can be attributed to excessive side loading may result in blade wear and degradation.The manual of tornado handpiece shaver mentioned that the optimal oscillate mode to the aggressive 5.00mm is 800 to 1500 rpm.Also, as per ifu; excessive side and the adequate suction is recommended to reduce wear and degradation of the device.The handpiece where the blade is assembled was not received for evaluation; also, the potential ways to reduce shedding is to ensure all hand pieces are properly serviced and maintained.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: AGGRESIVE 5.0MM 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10877260
• Report Number: 1221934-2020-03536
• Device Sequence Number: 2863598
• Product Code: HRX
• UDI-Device Identifier: 10886705022076
• UDI-Public: 10886705022076
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 283719
• Device Catalogue Number: 283719
• Device Lot Number: M1911049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/02/2020; 03/19/2021; 04/07/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/07/2020; 03/22/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1