MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number 71440366

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure, part of slap hammer broke off during extraction.Procedure completed with an smith&nephew backup device.Delay less than 30 minutes reported.No patient harm or additional complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the gii universal extractor confirms the device fractured into three pieces.All pieces were returned for evaluation.The device was manufactured in 2014.This instrument exhibits signs of extreme use and wear.A medical investigation was conducted and this case reports that part of the slap hammer broke off (outside of the patient) during extraction.A photo of the device confirms that it broke into three pieces.Per complaint details, the procedure was completed using a backup device with minimal delay and no patient injury.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch number 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.We consider this investigation closed.

• Brand Name: GII UNIVERSAL EXTRACTOR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10849270
• MDR Text Key: 216555927
• Report Number: 1020279-2020-06507
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010215192
• UDI-Public: 03596010215192
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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 Model Number: 71440366
• Device Catalogue Number: 71440366
• Device Lot Number: 14CM05544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention