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

Model Number	TWM
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information.Pending device evaluation.
Event or Problem 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
• Common Device Name: TORQUE WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10005302
• Report Number: 3001617766-2020-02531
• Device Sequence Number: 2785150
• Product Code: NDP
• UDI-Device Identifier: 10841307119265
• UDI-Public: 10841307119265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1