MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD RS HEX HAND PIECE ADAPTOR

Model Number RS9026

Device Problem Fracture (1260)

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

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

The doctor reported that the rs hex hand piece adaptor tip broke inside adin dental implant isps1335.Despite that no further 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.Only part of the fracured device and the implant were sent to the manufacturer for evaluation and therefore the phisical inspection is inconclusive.There was no irregularity in device manufacturing process.In the event that new or additional information is received from the investigation of the item, a follow-up report will be sent.Manufacturer's trend analysis show that fracture of driver is a low-rate adverse event.

Event Description

Fracture of dental hand instrument.

• Brand Name: RS HEX HAND PIECE ADAPTOR
• Type of Device: RS HEX HAND PIECE ADAPTOR
• 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: 18823514
• MDR Text Key: 336732072
• Report Number: 3007518363-2024-30995
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RS9026
• Device Catalogue Number: RS9026
• Device Lot Number: 7655306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention