MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PRSTHSS, KN, FMRTBL, NN-CNSTRND, CMNTD, MTL/PLYMR

Model Number 71441353

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  Injury  

Event Description

It was reported that a jrny uni tibial impactor broke when impacted a journey tka tibia implant.All broken pieces were removed.Procedure was finished with a smith and nephew back up device.There was no surgical delay.No harm or injury reported on patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per complaint details, the device bottom broke during impaction and all pieces were recovered.Reportedly, the procedure was completed without delay using a backup from s+n without patient injury, surgical delay, or other complications reported.No patient injury was alleged.The patient impact beyond the modified surgical procedure with use of a backup device could not be determined.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.A visual inspection confirmed the tip is broken off the jrny uni tibial impactor and has not been returned.The device shows significant signs of wear/usage.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 products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY UNI TIBIAL IMPACTOR
• Type of Device: PRSTHSS, KN, FMRTBL, NN-CNSTRND, CMNTD, MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10707522
• MDR Text Key: 212170621
• Report Number: 1020279-2020-05568
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588050
• UDI-Public: 03596010588050
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71441353
• Device Catalogue Number: 71441353
• Device Lot Number: 19JM09269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention