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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX KNOTLESS AWL 3.4MM; BONE AWL
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DEPUY MITEK LLC US HEALIX KNOTLESS AWL 3.4MM; BONE AWL Back to Search Results
Model Number 219495
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
 
Event Description
It was reported by sales rep via phone that during a rotator cuff repair it was noted that the edge of the tip of a healix knotless awl, 3.4 mm was blunted.A new device was used to complete procedure.No surgical delay or patient consequences was reported.
 
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 by sales rep via phone that during a rotator cuff repair it was noted that the edge of the tip of a healix knotless awl, 3.4mm was blunted.The complaint device was received and evaluated.Visual observations confirm that the distal tip of the device is slightly bent.The complaint can be confirmed.The possible root cause for the reported failure can be attributed when the device might have been dropped or device was tapped at an off angle or hit the bone accidentally at an off angle however, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:1904001, 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.
 
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.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.
 
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Brand Name
HEALIX KNOTLESS AWL 3.4MM
Type of Device
BONE AWL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10590578
MDR Text Key208715891
Report Number1221934-2020-02754
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10886705022373
UDI-Public10886705022373
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,other
Type of Report Initial,Followup,Followup
Report Date 09/10/2020
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 Number219495
Device Catalogue Number219495
Device Lot Number1904001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received09/25/2020
Supplement Dates Manufacturer Received10/07/2020
10/11/2020
Supplement Dates FDA Received10/09/2020
10/13/2020
Patient Sequence Number1
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