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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US AGGRESIVE 5.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
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DEPUY MITEK LLC US AGGRESIVE 5.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283719
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 11/03/2020
Event Type  malfunction  
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 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.
 
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).
 
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.
 
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.
 
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Brand Name
AGGRESIVE 5.0MM 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 Key10877260
MDR Text Key217986744
Report Number1221934-2020-03536
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022076
UDI-Public10886705022076
Combination Product (y/n)N
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283719
Device Catalogue Number283719
Device Lot NumberM1911049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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