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

Catalog Number 222295

Device Problems Break (1069); Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895)

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

Event Date 11/22/2023

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.Device was used for treatment, not diagnosis.Udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.The device was received with its packaging opened.It was evaluated.When performing the visual inspection, it was observed that the device was in its tray.The handle, suture and shaft do not show structural anomalies.The anchor was found broken into two pieces, the broken pieces were still attached to the inserter.A reddish line on the broken anchor edges was noted.The device was sent to the qa analytical laboratory to identify the the reddish matter found in the anchor.Infrared analysis was carried out by laboratory test method l tm-0002 revision e "identification of materials by infrared spectroscopy" and the use of ft-ir instrument was performed in accordance with qap-0706 rev.E.Overall, infrared spectroscopy results revealed that the foreign material exhibited the infrared spectrum for biological-based material.Source of origin remains unknown.A manufacturing record evaluation was performed for the finished device lot number: 169l489, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the ft-ir findings the out of the box failure cannot be sustained.However the complaint will be confirmed due to the anchor broken condition.A possible root cause can attributed to procedural variables, such handling of the devices or product interaction during procedure; axial misalignment may occurred and consequently cause the anchor to break.However this cannot be conclusively determined.As per ifu, inserting the awl or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.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.

Event Description

It was reported by the healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the anchor on the 4.5 healix advance br w/ocord device was broken off upon opening its package.During in-house engineering evaluation, it was determined that the device was broken into two pieces that were still attached to the inserter.It was further determined that a reddish line on the broken anchor edges was noted.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: 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: 18625053
• MDR Text Key: 334341432
• Report Number: 1221934-2024-00334
• 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,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: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222295
• Device Lot Number: 169L489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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