MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(4) that during an arthroscopic rotator cuff repair surgery on (b)(6) 2022, it was observed that the 6.5 healix advance br3sut w/oc device broke.There was no fragment left in the lesion.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.The device was brand new and the first use when the issue occurred.
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.Investigation summary: the complaint device was received and evaluated.Upon visual inspection, the anchor is attached to the inserter.The inserter shaft is not deformed or bent; no structural anomalies were found.A couple of threads on the middle section of the anchor were found with an irregular shape which suggest axial misalignment.Few threads of the anchor were found to be broken near the distal end.Rests of biological matter can be observed over the anchor and shaft.A manufacturing record evaluation was performed for the finished device 8l06088 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.A root cause for the broken and damaged anchor threads can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment or bending force was applied to the tip of the device, also, hard bone surface could have been found.As per ifu: axial misalignment or levering with the anchor upon insertion may result in anchor fracture.Do not apply a bending force to the inserter.This can damage the anchor or inserter tip.In hard bone, it is necessary to tap the pre-drilled bone hole.Insert the distal tip of the appropriate awl/tap into the pre-drilled hole until the threads are flush with the bone.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.
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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: 6.5 HEALIX ADVANCE BR3SUT W/OC
• Common Device Name: 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 ; 6013142063
• MDR Report Key: 13593835
• Report Number: 1221934-2022-00622
• Device Sequence Number: 5819726
• Product Code: MAI
• UDI-Device Identifier: 10886705021376
• UDI-Public: 10886705021376
• 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,Followup

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: 03/31/2024
• Device Model Number: 222301
• Device Catalogue Number: 222301
• Device Lot Number: 8L06088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 03/29/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/04/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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