MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222207

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 08/16/2022

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).Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the device was not received in its entire packaging.It could be observed that the anchor had a crack near the distal part; also, there are some dent marks on some parts of the anchor.A manufacturing record evaluation was performed for the finished device lot number (8l78018), and no non-conformance was identified.The process of the healix have phases where check the condition of the anchor, during the assembling anchor/suture, assembling anchor/suture/shaft, finals controls of the assembling products, inspection station pouch.This information corresponds to a process control to use to guarantee that the damage in the anchor can¿t have happened during manufacturing process.The root cause for the issue experienced by the customer could not be stablished.Based on the condition of the device received, the possible root cause could be attributed to the handling of the device and anchor interaction at the moment of open the packaging.However, it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.A further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of (b)(4) devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported by a healthcare professional in china that preoperatively to a rotator cuff repair surgery on (b)(6) 2022, it was observed that the anchor on the 5.5mm healix peek 3-suture anchor w/orthocord device was broken off upon opening its package.During in-house engineering evaluation, it was determined that the anchor had a crack near the distal part.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, 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: 16017713
• MDR Text Key: 307979571
• Report Number: 1221934-2022-04092
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 222207
• Device Catalogue Number: 222207
• Device Lot Number: 8L78018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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