MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR REAMER SHAFT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 71440324

Device Problem Break (1069)

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

Event Date 04/19/2021

Event Type  Injury  

Event Description

It was reported that, during a tka, the pin of the gii a/r fem sizing guide could not fit thru the sizing guide ((b)(4)).A gii quick connect handle could not stay engaged in block ((b)(4)).A gii univ ps femoral impactor broke while engaging ((b)(4)).The ring of the gii patellar reamer shaft was dislodged/came off, not sealed properly ((b)(4)).Instruments inside the patient.The procedure was completed without delay using a s+n back-up devices.Patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the reamer shaft is rounded off at both ends of the device.Also the ring came apart from the device.The ring was returned with the device.The instrument exhibits significant signs of wear/usage.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 any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PATELLAR REAMER SHAFT
• 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: 11805791
• MDR Text Key: 249965641
• Report Number: 1020279-2021-03983
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• Combination Product (y/n): N
• 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: 07/29/2021

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 Expiration Date: 11/20/2016
• Device Model Number: 71440324
• Device Catalogue Number: 71440324
• Device Lot Number: 06LM07665
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention