MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD SURGICAL TORQUE RATCHET 35-100 NCM

Model Number	RS6111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The doctor presented a complaint in malfunction of surgical torque ratchet rs6111 that fractured at time of use.Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it.As such, this event is reportable per 21 cfr part 803.In the event that new or additional information is received from the investigation of the items, a follow-up report will be sent.Manufacturer's trend analysis show that malfunction of ratchet is a low-rate adverse event.
Event or Problem Description
Fracture of ratchet.

• Brand Name: SURGICAL TORQUE RATCHET 35-100 NCM
• Common Device Name: SURGICAL TORQUE RATCHET 35-100 NCM
• Manufacturer (Section D): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer (Section G): ADIN DENTAL IMPLANT SYSTEMS LTD.; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer Contact: ilana lutvak ; industrial zone alon tavor; pob 1128; afula, ; IS
• MDR Report Key: 25618585
• Report Number: 3007518363-2026-01667
• Device Sequence Number: 9094196
• Product Code: NDP
• UDI-Device Identifier: 07290105156075
• UDI-Public: 07290105156075
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RS6111
• Device Catalogue Number: RS6111
• Device Lot Number: 7943406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown