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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US CORDCUTTER *EA; SUTURE CUTTER
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DEPUY MITEK LLC US CORDCUTTER *EA; SUTURE CUTTER Back to Search Results
Model Number 214646
Device Problem Dull, Blunt (2407)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter phone number: (b)(6).Udi: (b)(4).
 
Event Description
It was reported by a sales representative via email that during a shoulder arthroscopy, the cord cutter not cutting suture flush.The sales representative did not report surgical delay or 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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the procedure was completed without further problems.There was no surgical delay or patient consequences due to the event.H6: method codes: a manufacturing record evaluation was performed for the finished device [13p08] number, and no non-conformances were identified.
 
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 that the cord cutter not cutting suture flush.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device not being returned, 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.A manufacturing record evaluation was performed for the finished device [13p08] 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 Key10224736
MDR Text Key197769402
Report Number1221934-2020-01735
Device Sequence Number1
Product Code FZT
UDI-Device Identifier10886705004270
UDI-Public10886705004270
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,foreig
Type of Report Initial,Followup,Followup
Report Date 06/19/2020
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 Number214646
Device Catalogue Number214646
Device Lot Number13P08
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/19/2020
Initial Date FDA Received07/02/2020
Supplement Dates Manufacturer Received07/01/2020
08/21/2020
Supplement Dates FDA Received07/06/2020
08/21/2020
Patient Sequence Number1
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