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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK PANALOK ANCHOR; ANCHOR IMPLANTS
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DEPUY MITEK MITEK PANALOK ANCHOR; ANCHOR IMPLANTS Back to Search Results
Catalog Number 210024
Device Problems Failure To Adhere Or Bond (1031); Malfunction (2409)
Patient Problems Unknown (for use when the patient's condition is not known) (2202); Injury (2348)
Event Date 06/17/2015
Event Type  Injury  
Event Description
During an achilles repair, the customer's mitek panalok anchor pulled out.After it pulled out they decided to just do a repair through the bone with suture (bone was likely soft).No patient consequences.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.
 
Manufacturer Narrative
The complaint device was received and evaluated.There were no anomalies to the returned anchor that would have contributed in the reported pull out failure.Visual observation of the inserter revealed that the distal end is bent, which is a high possibility that this damage would have caused the anchor to fail and not get implanted correctly.This failure of the inserter is attributed to hitting a hard surface or applying excessive bending force while implanting the anchor, indicating mishandling of the device.Other than this possibility, a root cause is undetermined at this point.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.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.
 
Event Description
During an achilles repair, the customer's mitek panalok anchor pulled out.After it pulled out they decided to just do a repair through the bone with suture (bone was likely soft).No patient consequences.
 
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Brand Name
MITEK PANALOK ANCHOR
Type of Device
ANCHOR IMPLANTS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4910560
MDR Text Key6027989
Report Number1221934-2015-00863
Device Sequence Number1
Product Code MAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063273
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/24/2015,06/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Catalogue Number210024
Device Lot Number3804382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/17/2015
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer06/24/2015
Date Manufacturer Received06/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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