MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ #2-0PAN RB-1 W/BIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212852
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint devices are not being returned, therefore unavailable for physical evaluations.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.A non-conformance search was performed for this product code (212852), lot (3906240) 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.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.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep that during an ankle repair procedure when tugging on the sutures on two of the customer's minilok quick anchors + 2-0 pcryl with rb-1 to make sure fixation was in, the sutures broke and the anchors pulled out.The sales rep reported that the surgeon completed the procedure with a third device using the same bone hole with no patient consequences or delays.The sales rep stated that the patient's bone quality was hard and confirmed that no debris was left in the patient.The sales rep was not present for the case therefore could not provide any further information.The sales rep stated that the devices were discarded.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.

• Brand Name: MINILOK QA+ #2-0PAN RB-1 W/BIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8266465
• Report Number: 1221934-2018-52718
• Device Sequence Number: 16695131
• Product Code: MAI
• UDI-Device Identifier: 10886705002412
• UDI-Public: 10886705002412
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 212852
• Device Lot Number: 3906240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1