MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75 HEALIX ADVANCE KNTLSS BR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 222330

Device Problem Break (1069)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported by the sales rep in china that during an rotator cuff repair surgical procedure the 4.75 healix advance kntlss br device anchor was broken off, removed all the broken parts.Another like device was used to complete the procedure.There was no delay in the procedure reported.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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device date of manufacture is unknown at this time.Udi: (b)(4).The product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that 4.75 healix advance kntlss br was broken at the distal end of the anchor.Foreign matter was visible at the broken part.The proximal end was cracked.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the 4.75 healix advance kntlss br would contribute to the complained device issue.Based on the investigation findings, the potential cause for the broken anchor can be traced to off axis insertion and levering during insertion.As per the instructions for use; improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture or reduced performance, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: added.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS BR
• 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: 19087725
• MDR Text Key: 340183794
• Report Number: 1221934-2024-01182
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705023462
• UDI-Public: 10886705023462
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130917
• 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
• Report Date: 04/11/2024

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 Catalogue Number: 222330
• Device Lot Number: 237L002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1