MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS PLUS ANCHOR, W/ETHIBOND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212724
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2014
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.Investigation summary: evaluation statement- the complaint devices are not being returned, therefore are unavailable for a physical evaluation.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 no other complaints of any kind 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.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.Device history lot: the batch review 3669197 showed that the devices were conformed to in process and finished goods specifications when released to stock the 31 jan.2013.Expiration date: 2016-01 (according to retained labels).No nonconformance was opened.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
On deployment of both anchors the suture loop snapped.Changed to same like product to complete surgery.2 minute delay.No ae to patient.Additional information from the affiliate when the surgeon placed tension on the lead suture the loop of the bioknotless anchor snapped.The surgeon claims that not much tension was placed and he suspects the loop of the anchor was compromised as the anchor was hammered into the drill hole.The surgeon drilled additional holes to accommodate the additional anchors.Please see also medwatch report 1221934-2018-54212.

• Brand Name: BIOKNOTLESS PLUS ANCHOR, W/ETHIBOND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7723261
• Report Number: 1221934-2018-54213
• Device Sequence Number: 1040275
• Product Code: MAI
• UDI-Device Identifier: 10886705002108
• UDI-Public: 10886705002108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2014

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: 01/01/2016
• Device Catalogue Number: 212724
• Device Lot Number: 3669197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2014
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1