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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
Catalog Number 212843
Device Problem Failure to Advance (2524)
Patient Problem Not Applicable (3189)
Event Date 04/18/2019
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.(b)(6).Investigation summary despite multiple attempts made to the affiliate for the return of the complaint device, the device has not been received for evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part number, serial number combination.Review conducted per (b)(4) query executed on 7/9/2019.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.Udi: (b)(4).
 
Event Description
It was reported by the affiliate that the customer reported that the micro qa+ #3/0 oc v4 did not perform as expected.Additional information received from the affiliate reported the event occurred pre-op on (b)(6) 2019.It was also reported that the anchors did not hook appropriately which caused a surgical delay of an unknown amount of time.The affiliate reported the procedure was completed with other anchors.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary- the device was visually inspected under magnification, no anomalies were identified.Given the information provided we can not confirm the device is defective.A non-conformance search was performed and no non-conformances were identified for this part number (212843) with lot number (1l85568) combination per qlik search performed on (b)(6)2019.Therefore, we can not establish a definite root cause for the reported event.The complaint is not confirmed.The potential root cause for the reported failure is undetermined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy 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 was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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 Key8776859
MDR Text Key155204720
Report Number1221934-2019-57588
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Catalogue Number212843
Device Lot Number2L25154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2019
Date Manufacturer Received08/26/2019
Patient Sequence Number1
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