MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII XR TIBIA BASE IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74014451
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery.While inserting the base plate using the journey ii xr tibial base implant impactor, it was found that a piece of the plastic was broken.This piece was retrieved successfully.Surgery was completed with the same device, without any delay.No harm to the patient reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic of the device is cracked.The device shows signs of extensive use.The clinical/medical evaluation concluded that per case details, the broken tibial base impactor piece was retrieved from the patient.Two undated photos of the device were provided for review and confirm the reported breakage.There no patient injuries or adverse consequences reported.Since no patient injuries were reported, no further clinical assessment is warranted at this time.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.We consider this investigation closed.

• Brand Name: JII XR TIBIA BASE IMPLANT IMPACTOR
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12336617
• Report Number: 1020279-2021-06436
• Device Sequence Number: 11933819
• Product Code: JWH
• UDI-Device Identifier: 00885556687406
• UDI-Public: 00885556687406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74014451
• Device Catalogue Number: 74014451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: Required Intervention