MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR3SUT W/OC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222298
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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.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.H11 additional narrative: h4: the device manufacture date is currently unavailable.E1: the reporter¿s phone number was not provided.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 from japan that during an ¿orcr¿ open rotator cuff repair procedure, it was discovered that the anchor on the 5.5 healix advance br3sut w/oc device was broken during insertion.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.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.H4: the device manufacture date was unavailable in the initial medwatch report.The device manufacture date has been updated accordingly.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (109l310), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 5.5 HEALIX ADVANCE BR3SUT W/OC
• 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: 19721033
• Report Number: 1221934-2024-02409
• Device Sequence Number: 8207077
• Product Code: MAI
• UDI-Device Identifier: 10886705021345
• UDI-Public: (01)10886705021345(10)109L310(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 222298
• Device Lot Number: 109L310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown