MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN II BCS BOX PREP GD SZ6-8; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74012576
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during tka surgery, a jrn ii bcs box prep gd sz6-8 was used to prepare the femur for a 6 bcs femoral trial.It was noticed that not sufficient bone was removed, as the cam trial was unable to fit down.Surgeon used a saw to remove an additional 2mm of bone to allow the cam trail to fit.No significant surgical delay was reported.No other complications were reported.
Additional Manufacturer Narrative
H6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed and complaint could not be confirmed.The clinical/medical evaluation concluded that per complaint details, insufficient bone removal occurred medially with use of the ¿box prep with a 6 bcs trial femur¿ as the cam trial would not fit down¿; therefore, ¿used a saw to remove 2mm of bone to allow the cam trial to fit¿.It was communicated that there was "no injury" to patient and the "surgery was completed as normal".Since there was no alleged patient injury, no report of surgical delay and the surgery was successfully completed ¿as normal¿, no further medical assessment is warranted at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads of the device are damaged, rendering the device inoperative.The device also has some scratches and burrs.The device shows signs of extensive use.The clinical/medical evaluation concluded that per complaint details, insufficient bone removal occurred medially with use of the ¿box prep with a 6 bcs trial femur¿ as the cam trial would not fit down¿; therefore, ¿used a saw to remove 2mm of bone to allow the cam trial to fit¿.It was communicated that there was "no injury" to patient and the "surgery was completed as normal".Since there was no alleged patient injury, no report of surgical delay and the surgery was successfully completed ¿as normal¿, no further medical assessment is warranted at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.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.

• Brand Name: JRN II BCS BOX PREP GD SZ6-8
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11820008
• Report Number: 1020279-2021-04217
• Device Sequence Number: 3792273
• Product Code: JWH
• UDI-Device Identifier: 00885556001042
• UDI-Public: 00885556001042
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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,Followup
• Report Date (Section B): 08/25/2021

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: 74012576
• Device Catalogue Number: 74012576
• Device Lot Number: 14CBG0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/26/2021; 08/24/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/27/2021; 08/25/2021
• 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; Other; Required Intervention