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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK ANCHOR WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

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DEPUY MITEK LLC US VERSALOK ANCHOR WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Model Number 210808
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the anchor is unattached and the sutures were cut.The anchor plastic sleeve is slightly damaged due to the bone surface rubbing.Biological matter can be observed on the suture pieces.A manufacturing record evaluation was performed for the finished device 8l77954 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an incomplete insertion or poor bone quality may happen, as per ifu; bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or over-tensioning or poor bone quality may result in anchor pullout.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
 
Event Description
It was reported by a healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the versalok anchor with orthocord device could not be secured in the bone hole.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
 
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Brand Name
VERSALOK ANCHOR WITH ORTHOCORD
Type of Device
SOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key16420018
MDR Text Key310146777
Report Number1221934-2023-00858
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886705001224
UDI-Public10886705001224
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K063478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 Number210808
Device Catalogue Number210808
Device Lot Number8L77954
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2023
Initial Date FDA Received02/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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