MAUDE Adverse Event Report: Medos International SÃ rl CH TRIALTIS; DRIVER, PROSTHESIS

Catalog Number	5161005046
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction

• Brand Name: TRIALTIS
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): Medos International SÃ rl CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Micropulse Inc; 5865 e, in-14; columbia city IN 46725
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50616764
• Report Number: 1526439-2026-01399
• Device Sequence Number: 10512553
• Product Code: HWR
• UDI-Device Identifier: 10705034592268
• UDI-Public: (01)10705034592268(10)M1149881
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 5161005046
• Device Lot Number: M1149881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/14/2026
• 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