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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10653029
• Report Number: 1020279-2020-05281
• Device Sequence Number: 2727937
• Product Code: HRY
• UDI-Device Identifier: 03596010407351
• UDI-Public: 03596010407351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71440820
• Device Catalogue Number: 71440820
• Device Lot Number: 09HM10912
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: Required Intervention
• Patient Age: 60 YR