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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 257423262
• Report Number: 1020279-2021-05291
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556488454
• UDI-Public: 00885556488454
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 71434487
• Device Catalogue Number: 71434487
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1