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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, the femoral stabilising spike of a gii post ref a/p blk sz 6 sheared off and was retained in the femur.It is unknown if the spike was retrieved from the patient.It is also unknown how procedure was completed and if it was delayed as consequence of the product failure.Patient current health status is also unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post of the device is broken off and missing, rendering the device inoperative.The device shows signs of extensive use.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that per complaint details, the stabilizing spike sheared off the device and was retained in the femur.It is unknown if the fragment was recovered from the patient or how the procedure was completed.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The clinical root cause of the reported spike breakage could not be determined.The blocks are manufactured of 17.4 ph stainless steel and are intended as externally communicating devices which are not approved for long term internal tissue exposure; therefore, long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13838090
• Report Number: 1020279-2022-01233
• Device Sequence Number: 1308462
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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 Expiration Date: 09/19/2013
• Device Model Number: 71440820
• Device Catalogue Number: 71440820
• Device Lot Number: 09EM02889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown