MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CORKSCREW FEM HEAD REMOVER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,

Catalog Number 71930020

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  Injury  

Event Description

It was reported that during surgery the drill was out of the strait.There was a 15 minute delay.There was no injury reported but a competitor device had to be used to complete the surgery.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the tip of the device is broken off.The broken piece was not returned.Also the visual confirms the other end of the device is rounded off.There is also a slight curve/bend in the device.The device shows significant signs of wear/usage.The device was manufactured in 2020.A medical investigation was conducted and this case reports that during the procedure, the cork screw remover was "out of strait." a photo of the returned device shows that there is a slight curve/bend in the instrument.Per email communication, there was no patient injury, and the procedure was completed with a 15 minute delay, using a competitor device.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CORKSCREW FEM HEAD REMOVER
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814869
• MDR Text Key: 215461947
• Report Number: 1020279-2020-06334
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556049709
• UDI-Public: 885556049709
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71930020
• Device Lot Number: 20BM07466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention