MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROFIX QA PLUS W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and evaluated.Visual observation reveals that the distal end of the inserter shaft is bent.The anchor was missing and the ethibond suture is broken as reported.This complaint can be confirmed.However, the damage observed on the inserter shaft is consistent with applying excessive force while inserting the anchor beyond its intended use causing it to bend and suture to snap.This failure can be attributed to user technique error.A device history record (dhr) review has been conducted for the suture (product code: 108833) vendor lot number 14082018 and the 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 complaint for this lot of devices that were released to distribution.At this point in time, 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.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 or Problem Description
The customer facility reported via phone call that their microfix qa plus with orthocord failed during a brow lift procedure.The device tested fine then once in use the physician went to tie the suture and pulled the cord and it broke.No bone holes and no new bone holes created.The case was completed using another like device as this device was removed.There were no adverse patient consequences or time delay.The device will not be returned for evaluation.

• Brand Name: MICROFIX QA PLUS W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7781475
• Report Number: 1221934-2018-53299
• Device Sequence Number: 19441566
• Product Code: MAI
• UDI-Device Identifier: 10886705001903
• UDI-Public: 10886705001903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2017

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: 12/31/2017
• Device Catalogue Number: 212045
• Device Lot Number: 164931R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1