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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. QUICK COUPLING HANDLE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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SMITH & NEPHEW, INC. QUICK COUPLING HANDLE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Back to Search Results
Model Number 71170015
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Event Description
It was reported that the quick coupling handle got stuck and was hard to move back and forth.Surgery was resumed with a s+n back-up device without any delay.Patient was not harmed.
 
Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
QUICK COUPLING HANDLE
Type of Device
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11693223
MDR Text Key246244106
Report Number1020279-2021-03229
Device Sequence Number1
Product Code HSD
UDI-Device Identifier03596010180612
UDI-Public03596010180612
Combination Product (y/n)N
PMA/PMN Number
K121714
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71170015
Device Catalogue Number71170015
Device Lot Number451247
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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