MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL LUPINE BR DS W/ORTHCRD; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	210712
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
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, the anchor was pulled out (as the photo shows).No additional information could be provided.¿ the product has not returned to depuy synthes, however a photo was provided for evaluation.¿ visual inspection of the returned photo found the anchor detached from the sutures.The anchor and sutures had foreign matter, presumably biological residue.One of the sutures was broken and frayed.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the lupine br ds w/orthcrd 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 procedure.As stated on ifu 109002: residual bone fragments should be removed from the drilled hole site because they may interfere with proper placement or seating of the anchor.Do not use excessive tension or overload the suture.Doing so can lead to bone breakage and subsequent device pullout, or suture breakage.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.Document specification review: ifu 109002 device history lot: pn: 210712 lot number: 105jkk there was no non-conformance regarding this lot.Manufacturing date: 6 jan 2025 expiration date: 31 dec 2027 device history batch: null device history review: pn: 210712 lot number: 105jkk there was no non-conformance regarding this lot.Manufacturing date: 6 jan 2025 expiration date: 31 dec 2027 e1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during an unknown arthroscopic procedure that the lupine br ds w/orthcrd anchor device pulled out of the tissue.Another device was used to complete the procedure.There was a 10 min 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: added: d9, h6 investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection found that the anchor was detached from the inserter.Only the inserter and anchor with the suture loop were returned for evaluation.The anchor and inserter had foreign matter, presumably biological residue.No other anomalies could be observed.A functional test was unable to be performed due to the device returned incomplete/lacking components required for appropriate testing.The overall complaint was confirmed as the observed condition of the lupine br ds w/orthcrd would have contributed to the complained device issue.Based on the investigation findings, the potential cause could be traced to poor bone quality or incomplete insertion.As per instructions for use, incomplete insertion or poor bone quality may result in anchor pullout.Residual bone fragments should be removed from the drilled hole site because they may interfere with proper placement or seating of the anchor.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.Device history lot: there was no non-conformance regarding this lot.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 24590744
• Report Number: 1221934-2026-01041
• Device Sequence Number: 9531539
• Product Code: GAT
• UDI-Device Identifier: 10886705001101
• UDI-Public: (01)10886705001101(10)105JKK(17)271231
• 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): 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 Catalogue Number: 210712
• Device Lot Number: 105JKK
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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