MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ #2 PAN CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the complaint device was received and evaluated.Visual observation reveals that the inserter shaft is in two pieces and the anchor was not returned.The anchor is separated from the inserter and the suture is broken as reported.This complaint can be confirmed.However, the root cause for the damage observed on the suture cannot be determined.A 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 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 complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and 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.(b)(6).(b)(4).
Event or Problem Description
It was reported by the affiliate via email when placing the first anchor, the suture snapped although not much force was used on it.The procedure was completed with same like product.Additional information received via email from the affiliate on (b)(6) 2017 it is unknown what type of procedure this was it is unknown if the anchor was removed when the suture broke it is unknown if the surgeon used the original bone hole to complete the procedure when was the issue detected- unk it is unknown if there was a resulting surgical delay the procedure was able to be completed it is unknown if alternatives were readily available no patient impact.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7405962
• Report Number: 1221934-2018-50424
• Device Sequence Number: 13724177
• Product Code: JDR
• UDI-Device Identifier: 10886982152060
• UDI-Public: 10886982152060
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 06/30/2021
• Device Catalogue Number: 212134
• Device Lot Number: 3914645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 04/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1