MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 4.75 HEX TORQUE WRENCH ADAPT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71434487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroplasty two legion hk 4.75 hex torque wrench adapt ((b)(4)) broke, and the handle on one legion hk 4.75mm hex driver ((b)(4)) came loose.Instruments outside patient.Surgery was performed with back-up devices.Instruments were external to the patient.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEGION HK 4.75 HEX TORQUE WRENCH ADAPT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12038906
• Report Number: 1020279-2021-05291
• Device Sequence Number: 14368094
• Product Code: MBH
• UDI-Device Identifier: 00885556488454
• UDI-Public: 00885556488454
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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 Model Number: 71434487
• Device Catalogue Number: 71434487
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1