MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QUICK ANCHOR PLUS #2 ETHIBOND, CP-2 NEEDLE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2013
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 summary: the complaint device was returned and evaluated.The inserter was returned but the suture was not returned.We cannot confirm this complaint or discern a root cause for the reported failure.A batch record 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one similar complaint for this lot of devices that were released to distribution.Based on the overall complaint rate, at this point in time, 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 remetrex 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 purchasing agent for (b)(6) hospital reported that one of the sutures on their super quick anchor broke proximal to the anchor.She could not provide more information but was able to confirm there were no patient consequences or delay in the procedure due to the device's failure.

• Brand Name: SUPER QUICK ANCHOR PLUS #2 ETHIBOND, CP-2 NEEDLE
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7673181
• Report Number: 1221934-2018-51110
• Device Sequence Number: 1370056
• Product Code: JDR
• UDI-Device Identifier: 10886705001804
• UDI-Public: 10886705001804
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K930893
• 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): 07/08/2013

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: 03/01/2017
• Device Catalogue Number: 212032
• Device Lot Number: 3604054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2013
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1