MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440820

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that in a primary genesisii tkr procedure on a right knee while removing the post ref a/p femoral cutting block the securing pins fractured and remained in the femur.It took the surgeon approximately 15mins to remove them, he was able to complete the procedure with no further incident.The defective instrument is being cleaned for collection and inspection.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The cutting block exhibited wear in each of the cutting slots and damage to the impactor connection point which are consistent with product use.The cutting block bone spikes fractured at the cutting block interface.The fracture of the bone spikes is likely due to stresses in excess of its material properties being applied to the bone spike during use.The broken spikes were not returned.The device was manufactured in 2009.A medical investigation was conducted and this case reports that when removing the femoral cutting block, the securing pins fractured and remained in the femur.Per email communication, the pieces were removed with a forceps with no injury to the patient, and the procedure was completed with a delay of 15 minutes.Since no patient harm is alleged, no further clinical assessment is warranted at this time.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 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.

• Brand Name: GII POST REF A/P BLK SZ 6
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10653029
• MDR Text Key: 210575201
• Report Number: 1020279-2020-05281
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010407351
• UDI-Public: 03596010407351
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440820
• Device Catalogue Number: 71440820
• Device Lot Number: 09HM10912
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR