MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII XR TIBIA BASE IMPLANT IMPACTOR; PRSTHSISKNEEPTLLOFMRTIBILSMICNSTRINDCMNTDPLYMRMTALPLYMR

Model Number	74014451
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the tip of the device broke.Broken piece fell inside the body, but it was confirmed that the all pieces were retrieved from the body.
Additional Manufacturer Narrative
The device used in treatment was not returned for evaluation, reporting event could not be confirmed.Per photos attached, these photos confirms severe damage to the orange tips of the device.The photos don't show the lot number for this device.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.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.Small pieces of the plastic bumpers on the device fractured off and were not returned.The bumpers were heavily damaged around the fracture site.The device was manufactured in 2017 and shows signs of extensive usage.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.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.

• Brand Name: JII XR TIBIA BASE IMPLANT IMPACTOR
• Common Device Name: PRSTHSISKNEEPTLLOFMRTIBILSMICNSTRINDCMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9955316
• Report Number: 1020279-2020-01291
• Device Sequence Number: 2596622
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2020

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: 74014451
• Device Catalogue Number: 74014451
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 07/13/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/05/2020; 07/13/2020
• 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; Required Intervention