MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	210712
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the lupine br ds w/orthcrd device was broken (2+ pieces) : device fractured.It was initially reported that prior to a left ankle arthroscopic ligament repair surgery, upon opening the packaging, it was noted that the anchor was deformed.The device was not used.Three replacement devices had the same issue.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.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: e1: the reporter¿s complete facility address was not provided.Investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the shaft and handle have no structural anomalies.The anchor was found broken near mid-body and detached from the inserter.Not all the broken fragments were returned for evaluation.On the other hand, the anchor loop was lost.The device had signs of usage.No other anomalies were noted.The overall complaint was not confirmed as the observed condition of the lupine br ds w/orthcrd would have not contributed to the complained device issue.Based on the investigation findings, the potential cause for the broken and bent anchor as well as the frayed suture is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause is linked to an off-axis insertion and levering during insertion.As per instructions for use (ifu), 1) do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.2) excessive tension may overload the anchor or suture.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.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.Device history record review: a device history review was performed and no non-conformance's were identified related to the reported condition.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24377020
• Report Number: 1221934-2026-00795
• Device Sequence Number: 5572699
• Product Code: GAT
• UDI-Device Identifier: 10886705001101
• UDI-Public: (01)10886705001101(10)1027U9(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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 Catalogue Number: 210712
• Device Lot Number: 1027U9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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