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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 Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
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.Initial reporter phone number: (b)(6).Udi: (b)(4).
 
Event Description
It was reported that during the surgery of lateral malleolar ligament repair , when removed the shaft, noted the anchor was also pulled out.Another device was used to complete the surgery. there were no adverse consequences to the patient. no additional information could be 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.H10 additional narrative: d10, h3, h6: 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.H10 additional narrative: investigation summary:according to the information provided, it was reported that during the surgery of lateral malleolar ligament repair , when removed the shaft, noted the anchor was also pulled out.The complaint device was received and inspected.Visual inspection confirms that the mini anchor was found detached from the shaft inserter and was not held in place by the suture.In addition the suture was found slight frayed.The complaint can be confirmed.The possible root cause can be attributed to excessive tension applied in the suture.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: l982516, 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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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 Key10482304
MDR Text Key205302732
Report Number1221934-2020-02352
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
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 Number212035
Device Catalogue Number212035
Device Lot NumberL982516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Date Manufacturer Received09/27/2020
Patient Sequence Number1
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