MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.75 HEALIX ADVANCE KNTLS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222581
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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).The expiration date is currently unavailable.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 sales rep that during a rotator cuff repair on (b)(6) 2021, it was observed that the anchor device broke.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during a rotator cuff repair the 4.75 healix advance knotlesss br, the 5.5 healix advance knotlesss br and the 4.5mm healix advance peek multipack - 2 suture broke.The devices were returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.The two devices were received and evaluated.Visual observation revealed that the anchor was broken from the distal part but is held in place by the suture; therefore, this complaint can be confirmed.Also, one device had the suture out of the place.A manufacturing record evaluation was performed for the finished device lot number: 7l74477, and no non-conformances were identified.No additional information was provided about details of the procedure; therefore, a definitive root cause could not be determined.The possible root cause can be associated with off axis insertion and levering during insertion.Moreover, excessive force on the inserter could have resulted damage the anchor.However, it cannot be conclusively affirmed.As per ifu, ensure that anchor is inserted axially to the bone hole (limit off-axis insertion).Also, improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture or reduced performance.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: 4.75 HEALIX ADVANCE KNTLS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11569901
• Report Number: 1221934-2021-00983
• Device Sequence Number: 14352247
• Product Code: MAI
• UDI-Device Identifier: 10886705030309
• UDI-Public: 10886705030309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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 Model Number: 222581
• Device Catalogue Number: 222581
• Device Lot Number: 7L74477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/29/2021; 04/12/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 03/30/2021; 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1