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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TEARDROP HANDLE WITH LARGE AO; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TEARDROP HANDLE WITH LARGE AO; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71177131
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Event Description
It was reported that, after a trauma surgery, a 4.7mm ball hexdriver was stuck inside teardrop handle with large ao.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.
 
Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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 product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is 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
TEARDROP HANDLE WITH LARGE AO
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11822168
MDR Text Key250613256
Report Number1020279-2021-04280
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010601506
UDI-Public03596010601506
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/09/2021
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
Device Operator Health Professional
Device Model Number71177131
Device Catalogue Number71177131
Device Lot Number17DAB0014
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/28/2021
Initial Date FDA Received05/13/2021
Supplement Dates Manufacturer Received07/08/2021
Supplement Dates FDA Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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