MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SELF HOLDING HEX SCREWDRIVER; PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SEMICONSTRAIND,UNCMNTD,POROUS,COATD,POL

Catalog Number	71110026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the instrument was broken while being used.
Additional Manufacturer Narrative
Investigation results: the associated complaint device was returned and evaluated.A visual examination of the returned self-holding hex screwdriver indicated that the hex tip has fractured of and the screwdriver was disassembled.This fractured portion of the hex was not returned.This hex screwdriver was manufactured in 2006, showing sign of significant use/wear.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SELF HOLDING HEX SCREWDRIVER
• Common Device Name: PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SEMICONSTRAIND,UNCMNTD,POROUS,COATD,POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7448811
• Report Number: 1020279-2018-00785
• Device Sequence Number: 13940594
• Product Code: MBH
• UDI-Device Identifier: 03596010173034
• UDI-Public: 03596010173034
• Combination Product (Y/N): N
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: 71110026
• Device Lot Number: 06HM09422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1