MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD UNIFIT STAR HANDPIECE ADAPTER - MEDIUM

Model Number UF0071

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The doctor presented a general complaint in malfunction of unifit star torque drivers and handpieces.A fractured handpiece uf0071 was returned.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 21cfr 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 drivers is a low-rate adverse event.

Event Description

Fracture of driver.

• Brand Name: UNIFIT STAR HANDPIECE ADAPTER - MEDIUM
• Type of Device: UNIFIT STAR HANDPIECE ADAPTER - MEDIUM
• 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: 19057827
• MDR Text Key: 339550009
• Report Number: 3007518363-2024-00369
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Model Number: UF0071
• Device Catalogue Number: UF0071
• Device Lot Number: 7754201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention