MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL COMBO SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288211
Medical Device Problem Codes	Degraded (1153); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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.E1: the reporter¿s complete facility address was not provided.H11: 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.
Event or Problem Description
It was reported that post surgery, the bristow latarjet drill bit still had bone fragments in the threads, which suggests it was simply not properly cleaned after the previous case.It was also reported that the cannulated portion of the combo screwdriver was also filled with bone debris, and when it was cleaned, small particles of rust came out.The tray was not used in the or.This event did not occur during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.This is report 2 of 2 for (b)(4).The exact date of the event was unknown.However, it was reported that the event occurred in 2026.
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: the product has not returned to depuy synthes; however, a photo was provided for review.Visual inspection of the returned photo found that a brush with foreign matter, presumably biological residue visible.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the combo screwdriver would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to improper cleaning/maintenance.As per instructions for use.Prior to sterilization, instruments should be cleaned by either manual or automated means.Devices must be thoroughly cleaned prior to sterilization.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 review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• Brand Name: COMBO SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; la locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25015917
• Report Number: 1221934-2026-01715
• Device Sequence Number: 16025953
• Product Code: LXH
• UDI-Device Identifier: 10886705026890
• UDI-Public: (01)10886705026890(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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

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: 288211
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown