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	06/11/2024
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.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition.The device's handle and shaft have no structural anomalies.The anchor remains inside the inserter shaft.The anchor threads were found to be worn.Biological matter can be observed over the anchor.The overall complaint was confirmed as the observed condition of the 5.5 healix advance br3sut w/oc would contribute to the complained device issue.Based on the investigation findings, the potential root cause is traced to procedural variables, such handling of the device or product interaction during procedure; as per ifu inserting the awl less than the specified depth, 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.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 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.
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.H11 additional narrative: d4: the device expiration date was unknown in the initial report.The date of expiration has been updated accordingly.H4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.Udi: (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: d4: the device expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.D11: concomitant med products and therapy dates: 5.5 healix advance br w/ocord device, (b)(6) 2024.The investigation has been updated to reflect the correct information: investigation summary = > the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device is in used condition.The device's handle and shaft have no structural anomalies.The anchor remains inside the inserter shaft.Small cracks can be observed over the anchor threads.The overall complaint was confirmed as the observed condition of the 5.5 healix advance br3sut w/oc would contribute to the complained device issue.Based on the investigation findings, the potential root cause is traced to procedural variables, such handling of the device or product interaction during procedure; as per ifu, inserting the awl less than the specified depth, 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.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 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.
Event or Problem Description
Report 2 of 2 for (b)(4).It was reported by the healthare professional in china that during a rotator cuff repair surgical procedure on (b)(6) 2024 the 5.5 healix advance br3sut w/oc and 5.5 healix advance br w/ocord device anchors were broken off, removed all 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.

• 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 ; 3035526892
• MDR Report Key: 19594612
• Report Number: 1221934-2024-02158
• Device Sequence Number: 11757318
• Product Code: MAI
• UDI-Device Identifier: 10886705021345
• UDI-Public: 10886705021345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/24/2024

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: 08/31/2026
• Device Catalogue Number: 222298
• Device Lot Number: 226L661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 07/02/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/04/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown