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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283429
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
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. Investigation summary
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> according to the information provided, it was reported that during an unknown procedure the ultra aggressive plus 4. 0mm 5pk had metallic debris. The complaint device is not being returned, therefore unavailable for a physical evaluation. This complaint cannot be confirmed. Since the complaint device was not available, we cannot determine a root cause for the reported failure. If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate. The possible root cause for the reported failure can be attributed to interaction between two devices that cannot rotate freely. However; this cannot be conclusive determined. A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified. 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. Device history lot
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.
 
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
It was reported by the affiliate via complaint submission tool that during an unknown procedure the ultra aggressive plus 4. 0mm 5pk had metallic debris. No patient consequence was reported, however there was a 5 minutes surgical delay. No additional information was provided. Additional information provided by the affiliate reported 15 blades were involved in this complaint and the event occurred when the shaver was turned on at the beginning of a knee arthroscopic surgery. There were no known user or patient impacts due to the metallic shavings and the case was completed with a new blade. The reporter also stated the fragments were easily removed by washing the joint and additional surgical intervention is not required.
 
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Brand NameULTRA AGGRESSIVE PLUS 4.0MM 5PK
Type of DeviceARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9741873
MDR Text Key194847466
Report Number1221934-2020-00648
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283429
Device Catalogue Number283429
Device Lot NumberM1905040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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