MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222295

Device Problems Break (1069); Device Reprocessing Problem (1091); Device Damaged Prior to Use (2284)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

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 anchor was broken near the middle section, some biological residues were found in the anchor.Only the paper sheath and tray from its box packaging.The suture card was in place.Based on the condition of the anchor, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 7l08882, and no non conformances were identified.This issue was reviewed with the manufacturer; as a result, there are controls in place to 100% inspect the final conditions of the anchor to discard any damage (manufacturing with inspection standard work specification for healix advance br 2 sutures products, manufacturing with inspection tray setting, manufacturing with inspection product assembly).The manufacturing process has been performed according to the validated processes.Resistance of assembly has been evaluated in and the risk is acceptable.The results of production controls (100%) and in-process controls are all compliant based on the condition of the device received and the manufacturing information, a definite root cause cannot be determined.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 the affiliate in (b)(6) that during a rotator cuff repair procedure, it was observed that 4.5 healix advance br w/ocord device anchor was broken off.During an in-house engineering evaluation, it was determined that the anchor device was found to be broken near the middle section and biological residue was found in the anchor.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: 4.5 HEALIX ADVANCE BR W/OCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13316105
• MDR Text Key: 290532969
• Report Number: 1221934-2022-00268
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021314
• UDI-Public: 10886705021314
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 222295
• Device Catalogue Number: 222295
• Device Lot Number: 7L08882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1