MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL

Model Number	71441154
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during tka procedure, the spike on back of the gii mis dcf ap ct blk 6 broke off into femur.The spike was left inside the patient.Surgery was resumed, without any delay, with the same device.Patient's current health status is unknown.
Event or Problem Description
It was reported that, during tka, while removing the gii mis dcf ap ct blk 6, the surgeon noticed that the spike had broken off and remained in the bone.The spike was left inside the patient.Rep offered to get tephines to remove immediately, but surgeon refused due to the risk of removal.Surgery was not prolonged as consequence.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6; the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The spike is fractured off from the block, rendering the device inoperative.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that this case reports breakage of the dcf mis ap cutting block spike into the femur and the broken piece was not recovered from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, no clinical factors could be assessed which would have contributed to the reported spike (pin) breakage.The device is manufactured and intended as an externally communicating device and is not approved for long-term internal tissue exposure; therefore, long-term implantation data is not available.The patient impact beyond possible foreign body 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 can no 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 MIS DCF AP CT BLK 6
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL
• 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: 15399847
• Report Number: 1020279-2022-03998
• Device Sequence Number: 5057300
• Product Code: HRY
• UDI-Device Identifier: 03596010497222
• UDI-Public: 03596010497222
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2022

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 Model Number: 71441154
• Device Catalogue Number: 71441154
• Device Lot Number: 18CM19132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 10/04/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 09/29/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male