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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 +
• Common Device Name: 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
• Report Number: 1020279-2020-02723
• Device Sequence Number: 3408254
• Product Code: LZO
• UDI-Device Identifier: 00885556578612
• UDI-Public: 00885556578612
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1