MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BIOINTFX 6-8MMX30MM TPR SCR 2ND; SCREW, FIXATION, BONE

Catalog Number	254660
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
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.H11 additional narrative: e1: the initial reporter's complete facility address was not provided.Investigation summary the product has not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.¿ visual inspection of the returned photo found no observations pertaining to the nature of the reported event or any other anomaly.The overall complaint was not confirmed as the observed condition of the biointfx 6-8mmx30mm tpr scr 2nd would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence provided.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 j&j medtech orthopaedics 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.
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery, it was observed that the biointfx 6-8mmx30mm tpr scr 2nd device screw fell apart and was pulled out from the sheath.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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.H11 additional narrative: device history review: there was no non-conformance regarding this lot.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection found that the implant was returned for evaluation.No anomalies could be observed.The overall complaint was not confirmed as the observed condition of the biointfx 6-8mmx30mm tpr scr 2nd would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence provided.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 j&j medtech orthopaedics 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.

• Brand Name: BIOINTFX 6-8MMX30MM TPR SCR 2ND
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 22466309
• Report Number: 1221934-2025-02504
• Device Sequence Number: 19892326
• Product Code: HWC
• UDI-Device Identifier: 10886705013432
• UDI-Public: (01)10886705013432(10)133L301(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 01/31/2026
• Device Catalogue Number: 254660
• Device Lot Number: 133L301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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