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 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.The exp date is currently unavailable.The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes 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.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.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 sales rep that during an unspecified surgical procedure of the hand, it was observed that the customer's minilok quick anchor plus with 2/0 ethibond with v-5 device pulled out after insertion.The sales rep stated that the surgeon stated that the anchor was fine but he believes that the wrong size drill bit was packaged with the anchor.The sales rep stated that the surgeon removed the anchor with no issues.The sales rep reported that the surgeon completed the procedure with another like device using the same bone hole.The sales rep reported that there were no patient consequences or delays in the procedure.The sales rep could not provide the bone quality of the patient.The sales rep was not present for the case therefore could not provide any further information.The sales rep stated that the device was discarded.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: 8253367
• MDR Text Key: 134193785
• Report Number: 1221934-2019-56015
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002405
• UDI-Public: 10886705002405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2015

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: 3853336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/16/2019
• 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