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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #2/O OCORD V-5; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

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DEPUY MITEK LLC US MINI QA+ #2/O OCORD V-5; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE Back to Search Results
Model Number 212035
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).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 sales rep that during a mallet finger procedure on (b)(6) 2021, it was observed that the mini qa+ #2/o ocord v-5 anchor device did not deploy.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
 
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: the complaint device is not being returned, it was discarded by the customer, 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 (8l06239), 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.Device history lot: an mre review was performed and results obtained as below: product code: 212035, lot number: 8l06239, anomalies or discrepancies (non-conformance): none.
 
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Brand Name
MINI QA+ #2/O OCORD V-5
Type of Device
SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key12641385
MDR Text Key277144412
Report Number1221934-2021-03029
Device Sequence Number1
Product Code JDR
UDI-Device Identifier10886705001835
UDI-Public10886705001835
Combination Product (y/n)N
PMA/PMN Number
K071257
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 10/05/2021
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 Expiration Date03/31/2024
Device Model Number212035
Device Catalogue Number212035
Device Lot Number8L06239
Initial Date Manufacturer Received 10/05/2021
Initial Date FDA Received10/15/2021
Supplement Dates Manufacturer Received10/21/2021
Supplement Dates FDA Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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