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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REPAIR, STEM IMPACTOR ROD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

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SMITH & NEPHEW, INC. REPAIR, STEM IMPACTOR ROD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Catalog Number 71364011R
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Patient Involvement (2645)
Event Date 06/04/2020
Event Type  malfunction  
Event Description
It was reported that the threads of a stem impactor rod are stripped.No case involved.
 
Manufacturer Narrative
H3, h6: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the threads are broken off the repair, stem impactor rod 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.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.
 
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Brand Name
REPAIR, STEM IMPACTOR ROD
Type of Device
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10192388
MDR Text Key196426435
Report Number1020279-2020-02707
Device Sequence Number1
Product Code JDG
UDI-Device Identifier00885556529621
UDI-Public885556529621
Combination Product (y/n)N
PMA/PMN Number
K123598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/07/2015
Device Catalogue Number71364011R
Device Lot Number05DM16526
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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