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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK THREADER TAB *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

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DEPUY MITEK LLC US VERSALOK THREADER TAB *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE Back to Search Results
Catalog Number 210800
Device Problem Retraction Problem
Event Date 10/03/2016
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. Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. We cannot discern a root cause for the reported failure mode. A non-conformance search was performed for this part-lot combination and no non-conformances were identified. At this point in time, no corrective action is required and no further action is warranted. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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. This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions. (b)(4).

 
Event Description

The surgeon made a hole with a special awl. Due to the slight different insertion angle of the anchor, the anchor came off after the insertion. It was brand new and the first use when the issue occurred. The surgery was completed with a 5-minute delay. Additional information was received via email from the affiliate on 10-12-2016. It is not known what type of bone quality the patient had an awl was used to prep the bone hole. It is not known if the anchor was still attached to the inserter when the inserter was removed. It is not known if the anchor fell in the patient. It is not known if the original bone hole was used to complete the procedure. The backup device was used to complete the case.

 
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Type of DeviceSOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham , MA 02767
6103142063
MDR Report Key8317294
Report Number1221934-2019-56350
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device Catalogue Number210800
Device LOT Number3901123
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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