MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 16 +; PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD

Model Number 71354632

Device Problem Break (1069)

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

Event Date 06/01/2020

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the item was found broken.No injuries or surgical delays were reported.No information about backup devices was provided.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned redapt distal reamer 240mm size 16 and redapt trial body sz 16 confirms the devices are stuck together.The devices can¿t be separated.The redapt trial body sz 16 was manufactured in 2017.The lot number on the redapt trial body sz 16 cannot be seen because the devices are stuck together.These devices show significant signs of wear and usage.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REDAPT TRIAL BODY SZ 16 +
• Type of Device: PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10193952
• MDR Text Key: 196394284
• Report Number: 1020279-2020-02723
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556578612
• UDI-Public: 00885556578612
• Combination Product (y/n): N
• PMA/PMN Number: K151902
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71354632
• Device Catalogue Number: 71354632
• Device Lot Number: 17CPG0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1