MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222362
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Additional narrative: udi: (b)(4).Expiration date is currently unavailable.The device manufacture 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
This is report 1 of 2 for (b)(4).It was reported by a healthcare professional in austria that postoperatively to a rotator cuff repair procedure initially performed on (b)(6) 2022, the patient had a revision surgery on (b)(6) 2023 due to continuous pain for approximately three weeks after the initial surgery in the shoulder joint.According to the report, during the revision surgery, the surgeon recognized that the bridge on the 5.5mm healix advance¿ br anchor with permatape¿ suture, white/blue device was broken for the medial row anchor.Additionally, he recognized, that the 5.5mm healix advance knotless br anchor device for the lateral row did not tighten the repair - meaning that the tape got loose between the outer anchor body and the bone.It was reported that both anchors were removed and another like devices were implanted into the new bone holes.It was reported that no problem was recognized during the initial surgery as the media showed a solid construct during the primary surgery where the knots on the medial side were solid fixed as well as the lateral fixation.It was reported that due to the ongoing pain of the patient and an mr scan, the surgeon decided to have a second look.It was reported that at the revision surgery, the media still showed good fixation of the knots and a solid tape/suture construct from medial to lateral but the tendon-bone contact medial got loose ¿ due to the broken bridge the tape/suture lost its fixation inside the healix advance anchor.It was reported that there was no fixation between the underside of the tendon and the bone/anchor.It was reported that the surgeon recognized that the tape/sutures from medial to lateral could be removed easily from the bone-anchor fixation on the lateral side.It was reported that the surgeon also recognized and documented by media, that the medial helaix anchor was also damaged close to the cortical bone ¿ meaning on the proximal part of the anchor.It was reported that the surgeon believed that if the anchor had broken during the primary surgery, he would have recognized it directly and it would not have been possible to create a solid bone-tendon contact/pressure with the knots tied on the upper tendon part medially.It was reported that the surgeon was clear that the break of the bridge in between the medial healix anchor occurred after the primary surgery.It was reported that the patient was doing good after the revision surgery.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 has not been returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that the anchor was broken and the suture was loose.Therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 9l60802, and no nonconformances were identified.The photos do not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.The healix anchor has a bar (bridge) that the suture material loops over holding the suture in the anchor.If that small bar breaks, the suture will become loose and will not hold the tendon/ligament repair down onto the bone.In nearly all instances of the repair coming loose, failing, inability to tighten the suture, it is because this bar has broken from excessive force, making it impossible for the anchor to hold the suture.However, it cannot be conclusively affirmed.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.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).

• Brand Name: 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16264765
• Report Number: 1221934-2023-00559
• Device Sequence Number: 4338080
• Product Code: MAI
• UDI-Device Identifier: 10886705027828
• UDI-Public: 10886705027828
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 222362
• Device Catalogue Number: 222362
• Device Lot Number: 9L60802
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 01/17/2023; 02/13/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/10/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown