MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEX SCREWDRIVER LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71170133
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while doing pre-checks before a hardware removal case, it was noticed that the hex screwdriver large is warped/ cracked and is unable to use it.A s&n back up device was available to complete the procedure.There was a delay of less than 30 min.No injuries reported at this time.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the device is twisted/ warped, rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: HEX SCREWDRIVER LARGE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11168563
• Report Number: 1020279-2021-00379
• Device Sequence Number: 14252640
• Product Code: HRY
• UDI-Device Identifier: 03596010181329
• UDI-Public: 03596010181329
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2021

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: 71170133
• Device Catalogue Number: 71170133
• Device Lot Number: 18JT10260
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 05/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1