MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 3.4MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222343
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional 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.Udi: (b)(4).Concomitant medical devices and therapy dates, lupine br ds w/orthcrd, may 8, 2024.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported by the sales rep that during an unspecified surgical procedure the healix br 3.4mm device was cracked before implanting and the lupine br ds w/orthcrd device suture broke prematurely.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.This is report 1 of 2 for (b)(4).
Additional 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.H11 additional narrative: investigation summary: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Upon visual inspection of the photos, it was noted that the device packaging is not shown, only a partial part of the shaft and the entire condition of the anchor are visible.The device appears to be in used condition, the anchor is cracked.The manufacturer performed an investigation with the photo provided by the customer with the following results; an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also pert (b)(4), visuel d'inspection pour la famille healix rev:w, none of the 9 parts were non-conformed.A manufacturing investigation activity was conducted to determine if there were any internal processing issues that may have contributed to the nature of the product complaint.A thorough review of production process controls was conducted.The results show that this batch of product was processed without incident.The overall complaint was confirmed as the observed conditions of the healix br 3.4mm would contribute to the complained devices issue.Based on the investigation findings the potential root cause can be traced to procedural variables, such handling of the device, or product interaction before procedure; the device could have been mishandled consequently the device fracture was caused.Therefore 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 reported 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.Device history review: there was no non conformance regarding this lot.
Additional 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.

• Brand Name: HEALIX BR 3.4MM
• Common Device Name: 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: 19391593
• Report Number: 1221934-2024-01722
• Device Sequence Number: 20527196
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 222343
• Device Lot Number: 128L897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 06/11/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/07/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown