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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN FLEXIBLE REAMER SHAFT W/EXT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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SMITH & NEPHEW, INC. TRIGEN FLEXIBLE REAMER SHAFT W/EXT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number E0014834
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2019
Event Type  malfunction  
Event Description
Surgeon states reamer shaft buckled during reaming.S&n backup was used.No delay to procedure, no injury to patient.Device will be returned.
 
Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, 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
TRIGEN FLEXIBLE REAMER SHAFT W/EXT
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8497264
MDR Text Key141384957
Report Number1020279-2019-01479
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE0014834
Device Lot Number121015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2019
Date Manufacturer Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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