MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ #2-0 ETH V-5 W/BIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 212851

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).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.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.A non-conformance search was performed for this product code 212851, lot #3882019 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the affiliate in (b)(6) that during a foot operation for a haglund syndrome on the left heel, it was observed that the minilok qa+ #2-0 eth v-5 w/bit anchor device was torn out of the bone.According to the reporter, the device did not stay in the bone.The surgery continued with another techniques but was prolonged for 20 minutes approximately.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MINILOK QA+ #2-0 ETH V-5 W/BIT
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8258200
• MDR Text Key: 133526156
• Report Number: 1221934-2018-51601
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002405
• UDI-Public: 10886705002405
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2016

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 Catalogue Number: 212851
• Device Lot Number: 3882019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1