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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2021-03983
• Device Sequence Number: 19744369
• Product Code: MBH
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention