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

Catalog Number 210800

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.

Event Description

It was reported that the product was used for the arcr (arthroscopic rotator cuff repair) on (b)(6) 2018.During the removal of the last inserter, the surgeon could not detach veralok anchor from the implant.It was brand new and the first use when the issue occurred.The surgery was completed without a delay.There was no harm to the patient.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code (b)(4), lot l689869 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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)(4).

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7500341
• MDR Text Key: 108225948
• Report Number: 1221934-2018-50611
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 210800
• Device Lot Number: L689869
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1