MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMHS 75 IN-LB TORQUE WREN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	115188
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a revision surgery, torque wrench was noticed to be too stiff, causing the hex driver to strip as a result.Procedure continued with a backup device from smith and nephew, without a delay or an injury.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The revision sugery, in which our product allegedly malfunctioned, was not performed for smith & nephew products.Therefore, the re-assessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report had been made based upon information that smith & nephew had not been able to investigate or verify before.

• Brand Name: IMHS 75 IN-LB TORQUE WREN
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10687630
• Report Number: 1020279-2020-05453
• Device Sequence Number: 3449978
• Product Code: KTT
• UDI-Device Identifier: 03596010053008
• UDI-Public: 3596010053008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: Health Professional
• Device Catalogue Number: 115188
• Device Lot Number: 042673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1