MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI INS TRIAL SZ 3-4 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery the trial broke upon removal after trailing components.No delay or injury reported.It is unknown how the procedure was finished.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during surgery the trial broke upon removal after trialing components.All pieces were recovered.No delay reported.The procedure was completed as normal with the intended prothesis being implanted.Trialing was complete at the time of breakage.There was no need for a backup device.No changes to technique were needed.
Additional Manufacturer Narrative
H3, 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 is broken into several pieces, rendering the device inoperable.The clinical/medical investigation concluded that per complaint details, the trialing was complete at the time of breakage and the procedure was completed as planned without the need for a backup device or change in surgical technique.No injury or delay was reported, therefore, no further medical investigation 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.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.

• Brand Name: JII UNI INS TRIAL SZ 3-4 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11089416
• Report Number: 1020279-2020-07925
• Device Sequence Number: 16811021
• Product Code: HSX
• UDI-Device Identifier: 00885556577677
• UDI-Public: 00885556577677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: Other
• Device Model Number: 71935104
• Device Catalogue Number: 71935104
• Device Lot Number: 16KAP9750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 07/15/2021
• 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