MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN II BCS BOX PREP GD SZ3-5; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74012575
Medical Device Problem Codes	Naturally Worn (2988); Sharp Edges (4013)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka procedure, three journey ii bcs box prep gd size 3-5 are worn down leaving metal shavings in patient.Also sharp and jagged from excessive use.There was a technique change for completing the procedure.Instruments inside the patient.No delay reported.
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device worn down and contains burrs due to use over time, which may have caused the appearance of the metal shavings.The device shows signs of extensive use.The clinical/medical investigation concluded that this case reports that during a tka surgery, three box prep guides were worn down and left metal shavings inside the patient.Per email correspondence, suction was used to retrieve metal shavings.The procedure was completed using a change in technique, with no harm to the patient or delay.Therefore, no further clinical assessment is warranted.A review of complaint history did not reveal additional complaints for the listed batch.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 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.Should 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
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that this case reports that during a tka surgery, three box prep guides were worn down and left metal shavings inside the patient.Per email correspondence, suction was used to retrieve metal shavings.The procedure was completed using a change in technique, with no harm to the patient or delay.Therefore, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.

• Brand Name: JRN II BCS BOX PREP GD SZ3-5
• 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: 11357015
• Report Number: 1020279-2021-01509
• Device Sequence Number: 4107503
• Product Code: JWH
• UDI-Device Identifier: 00885556000991
• UDI-Public: 00885556000991
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

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: 74012575
• Device Catalogue Number: 74012575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 07/19/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 07/05/2021; 07/19/2021
• 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