MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PEEK ANCHOR W/ FREE STRANDS OF #2 ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2013
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.The complaint device was received and evaluated.Visual observation revealed that the eyelet on the peek pin is broken and the anchor is stuck on the inserter shaft.It was reported that the patient had hard bone.Ifu indicates using an awl while inserting into hard bone.This failure can be attributed to user technique issues.A batch record review has been conducted to determine if there were any internal processing issues that 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 mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.Based on the overall complaint rate, at this point in time, no corrective action is required and no further action is warranted.However, 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
Our affiliate reported on insertion, the versalok anchors broke distally.All 3 anchors were from the same lot number.Replaced with the same device from a different lot number and case proceeded.No further information are available at this stage.Please see also medwatch reports 1221934-2018-53554 and 1221934-2018-53555.

• Brand Name: VERSALOK PEEK ANCHOR W/ FREE STRANDS OF #2 ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7790589
• Report Number: 1221934-2018-53556
• Device Sequence Number: 11056517
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2013

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: 05/01/2016
• Device Catalogue Number: 210818
• Device Lot Number: 3706352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2013
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1