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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 DEPTH GAUGE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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SMITH & NEPHEW, INC. R3 DEPTH GAUGE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 71364451
Device Problem Material Separation (1562)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2020
Event Type  Injury  
Event Description
It was reported that during surgery, the r3 depth gauge snapped into two pieces while the surgeon was using it.Both pieces were recovered and nothing was left in the patient.Procedure concluded with the same device.No delay or injury reported.
 
Manufacturer Narrative
H3, h6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed and complaint could not be confirmed.The clinical/medical investigation concluded that per complaint details, the device broke during use; however, "both pieces were recovered, and nothing was left in the patient".Since the procedure concluded with the same device and no surgical delay or patient jury was reported, no further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.This device 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.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 or product information, 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.
 
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Brand Name
R3 DEPTH GAUGE
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10381217
MDR Text Key202108976
Report Number1020279-2020-03785
Device Sequence Number1
Product Code KTT
UDI-Device Identifier03596010599438
UDI-Public03596010599438
Combination Product (y/n)N
PMA/PMN Number
K093047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71364451
Device Catalogue Number71364451
Device Lot Number13BM10802
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received08/07/2020
Supplement Dates Manufacturer Received07/27/2021
Supplement Dates FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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