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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO PUSHER/CUTTER *EA; SUTURE CUTTER
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DEPUY MITEK LLC US ARTHRO PUSHER/CUTTER *EA; SUTURE CUTTER Back to Search Results
Model Number 228302
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
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.Udi: (b)(4).
 
Event Description
It was reported by sales rep via complaint submission tool that the pusher/cutter 228302 was not cutting.Had another pusher/cutter in tray that was used.No surgical delay.No patient consequences.
 
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: 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.Investigation summary according to the information provided, it was reported by sales rep via complaint submission tool that the pusher/cutter was not cutting.The complaint device was received and evaluated.Functional test was performed, when the trigger was tested, it feels rough as though the internal components are worn.A thread was loaded to test its functionality, it does not cut the thread cleanly, confirming this complaint.The possible root cause for the reported failure can be attributed to fair wear and tear of the device from repeated use and sterilization cycles.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [18p13] 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 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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Type of Device
SUTURE CUTTER
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10363143
MDR Text Key202230151
Report Number1221934-2020-01996
Device Sequence Number1
Product Code NBH
UDI-Device Identifier10886705010172
UDI-Public10886705010172
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 07/18/2020
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
Device Operator Health Professional
Device Model Number228302
Device Catalogue Number228302
Device Lot Number18P13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Initial Date Manufacturer Received 07/18/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received08/12/2020
08/14/2020
Supplement Dates FDA Received08/13/2020
08/14/2020
Patient Sequence Number1
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