MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC TWM; TORQUE WRENCH

Model Number TWM

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

No information.Pending device evaluation.

Event Description

Per complaint (b)(4), during a review of finished goods inventory currently, it was discovered that a torque wrench was packaged with incorrect instructions for use.

• Brand Name: TWM
• Type of Device: TORQUE WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 10005302
• MDR Text Key: 189186315
• Report Number: 3001617766-2020-02531
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119265
• UDI-Public: 10841307119265
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TWM
• Device Catalogue Number: TWM
• Device Lot Number: 143685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Date Manufacturer Received: 01/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2019
• 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