MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK THREADER TAB *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 210800

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The batch review 3682711 showed that the 300 devices were conformed to in process and finished goods specifications when released to stock the 3 apr.2013.Expiration date: 2016-03 (according to retained labels).No non-conformance (nc) was opened.Evaluation statement: the complaint device is not being returned, it was discarded by the customer and therefore is 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 one other dissimilar complaint 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that when the surgeon attached the anchor to the gun, the surgeon felt loosening between the devices slightly.The surgeon stopped using the anchor.Another versalok anchor was used, the surgery was completed.The versalok gun was in the locked position when connected to the inserter shaft of the anchor.It is unknown if the inserter shaft of the anchor and versalok gun clicked firmly into place when connected.It is also unknown if the surgeon was manually tensioning sutures or using the tensioning wheel of the versalok gun.The same versalok gun was used with another versalok anchor to complete the case.The complaint devices were discarded by the customer.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7660104
• MDR Text Key: 113337326
• Report Number: 1221934-2018-50957
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 210800
• Device Lot Number: 3682711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1