MAUDE Adverse Event Report: DEPUY MITEK LLC US GII® QUICKANCHOR® PLUS, SINGLE PACK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 212034

Device Problems Difficult to Advance (2920); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Reporter is a j&j employee.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the affiliate in japan that during a rotator cuff repair procedure for proximal end of humerus fracture performed concurrently with osteosynthesis on 10/17/2022, it was observed that the gii® quickanchor® plus, single pack device came off after deployment when the suture was pulled.According to the report, the sliding part of the device for releasing sutures was too hard/tight, and the surgeon had considerable difficulty in removing sutures.It was further reported that after osteosynthesis using a plate, the surgeon intended to fix the rotator cuff by inserting the g2 anchor in question as if to make a suture bridge.But the surgeon gave up the procedure because the anchor in question was not deployed fully enough.Although there had been a spare g2 anchor, the surgeon did not use it.The surgery was completed successfully within 30 minutes delay.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (9l05410), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.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.

• Brand Name: GII® QUICKANCHOR® PLUS, SINGLE PACK
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15716754
• MDR Text Key: 305046354
• Report Number: 1221934-2022-03399
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001828
• UDI-Public: 10886705001828
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212034
• Device Catalogue Number: 212034
• Device Lot Number: 9L05410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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