MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 8; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71440824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total knee arthroplasty the cutting block was placed on the femur, hit into place with the hammer, and cuts were made.When the cutting block was removed, it was noticed that the securing pin/spike on the back of cutting block had snapped off and was stuck in the femur.The pieces were removed by the surgeon with forceps.Another device was not necessary.The procedure was finished using the same device.No delay or patient injury was reported.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports that during a tka, the securing pin broke off of the cutting block and became stuck in the femur.Per complaint details, the surgeon removed the piece with a forceps.There was no patient injury reported, and the procedure was completed with less than 30 minutes delay; a backup device was not necessary.Since no patient harm is alleged, no further clinical assessment is warranted.A visual inspection confirmed one of the posts is broken off the gii post ref a/p blk sz 8 and has not been returned.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 POST REF A/P BLK SZ 8
• 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: 10730896
• Report Number: 1020279-2020-05721
• Device Sequence Number: 4123158
• Product Code: MBH
• UDI-Device Identifier: 03596010407375
• UDI-Public: 03596010407375
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Model Number: 71440824
• Device Catalogue Number: 71440824
• Device Lot Number: 09GM09075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 04/15/2021
• 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; Required Intervention