MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX BR ANCHOR W/OCORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 222229

Device Problems Break (1069); Material Frayed (1262); Shipping Damage or Problem (1570); Device Damaged Prior to Use (2284)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that before a rotator cuff repair surgery on (b)(6) 2023, it was observed that the packing (did not use) was opened and it was noted that the healix br anchor w/orthocord device was broken off.Changed to another one to continue the surgery, and the same problem happened again.During in-house engineering evaluation, it was determined that the suture was damaged - frayed, and the device was fractured and had foreign substance/debris/cleaning/sterilization.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the deployer and the anchor with the suture attached were returned for evaluation.The anchor was found broken at the proximal part and the green suture was frayed.The deployer does not show structural anomalies, the handle has foreign matter, presumably biological matter which can be related to the use of the device.Therefore, this complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 141l237, and no nonconformances were identified.The customer reported a non-used device, however the physical device shows evidence of use.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment may have been applied.As per ifu, apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Udi: (b)(4).

• Brand Name: 4.5 HEALIX BR ANCHOR W/OCORD
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 18525383
• MDR Text Key: 333030063
• Report Number: 1221934-2024-00133
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705007769
• UDI-Public: 10886705007769
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222229
• Device Lot Number: 141L237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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