MAUDE Adverse Event Report: DEPUY MITEK LLC US GII EASY ARTHRO #2 ETH *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212450
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices are not being returned, therefore are unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for any of these potential lots that were released to distribution.A device history review has been conducted for lot number 3929285 since it was reported that quantity of (2) devices were used from this lot.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.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 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 3 of 3 for the same event.It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that three anchors where the suture fretted and broke under minimal tension in a g2 anchor.It was reported that two had been switched out for orthocord.It was reported that the anchors were being used to 'shuttle' the distal biceps tendon down having been whip stitched by one limb of suture.According to the reporter, the sutures frayed on a 'sharp edge' at the islet.It was reported that the procedure was extended by 15 minutes.There was no patient harm as further anchors were placed into the same drill holes to secure the tendon.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.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8270285
• Report Number: 1221934-2018-53138
• Device Sequence Number: 158875
• Product Code: JDR
• UDI-Device Identifier: 10886705002061
• UDI-Public: 10886705002061
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K915889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 212450
• Device Lot Number: 3929285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1