MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.5HLX ADV BR ANC-DYNA STR/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure that the 4.5hlx adv br anc-dyna str/bl anchor device when tightened the suture, the suture broke off.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.According to the information received, it was reported that during the surgery, when tightened the suture, the suture was broken off (as the attached photo shows).No additional information could be provided.The product has not returned to depuy synthes, however a photo was provided for review.Visual inspection of the returned photo found that the implant was detached from the suture.The suture was broken and frayed at the proximal end.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the 4.5hlx adv br anc-dyna str/bl would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause could be traced to excessive tension applied to the suture during implant.As per ifu- 116034, apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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 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.Document specification review: ifu-116034 device history lot: pn: 222001 lot number: 240l540 there was a non conformance (nr-0215765) not related.Manufacturing date: 18/oct/2023 expiry date: 30/sep/2026 device history batch: null device history review: pn: 222001 lot number: 240l540 there was a non conformance (nr-0215765) not related.Manufacturing date: 18/oct/2023 expiry date: 30/sep/2026 e1: the reporter¿s complete facility address was not provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: added: d4 expiration date, h4.Correction: d4 primary udi number.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.

• Brand Name: 4.5HLX ADV BR ANC-DYNA STR/BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24583073
• Report Number: 1221934-2026-01058
• Device Sequence Number: 21421345
• Product Code: MAI
• UDI-Device Identifier: 10886705029402
• UDI-Public: (01)10886705029402(10)240L540(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 09/30/2026
• Device Catalogue Number: 222001
• Device Lot Number: 240L540
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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