MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYINTERACTIVE DRIVER; WRENCH, LONG

Catalog Number	HT2.7L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the hand driver became stuck inside of two separate implants, resulting in the implants removal.This complaint is for the tool associated with 3500a 3001617766-2019-00059 and 3001617766-2019-00060.

• Brand Name: SIMPLYINTERACTIVE DRIVER
• Common Device Name: WRENCH, LONG
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8449996
• Report Number: 3001617766-2019-00096
• Device Sequence Number: 10848873
• Product Code: NDP
• UDI-Device Identifier: 10841307119876
• UDI-Public: 10841307119876
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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: No Information
• Device Catalogue Number: HT2.7L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR