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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 OC V4; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
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DEPUY MITEK LLC US MICRO QA+ #3/0 OC V4; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE Back to Search Results
Model Number 212843
Device Problem Migration or Expulsion of Device (1395)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 09/02/2020
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).The lot number is unknown at this time.
 
Event Description
It was reported via complaint submission tool that during a tendon repair surgeon reported that a micro qa plus w/ #3/0 suture pulled out after insertion into drilled hole.She asked for advice on whether to re-try same implant, or another.It was suggested to use a bigger sized similar implant.No surgical delay or patient consequences reported.Additional information provided by the affiliate reported " the product was implanted, and successfully, it was the only implant used to complete the repair.The affiliate also reported the device is not available to be returned.
 
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: d4, h4: the lot number, expiration date and manufacture date were reported as unknown on the initial report and have been updated accordingly.Therefore, 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: investigation summary -the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (l982514), and no non-conformance was 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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Brand Name
MICRO QA+ #3/0 OC V4
Type of Device
SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10555467
MDR Text Key207586215
Report Number1221934-2020-02664
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886705002375
UDI-Public10886705002375
Combination Product (y/n)N
PMA/PMN Number
K080352
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 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model Number212843
Device Catalogue Number212843
Device Lot NumberL982514
Was Device Available for Evaluation? No
Date Manufacturer Received10/16/2020
Patient Sequence Number1
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