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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674002
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
It was reported that, during surgery, the lag screw drill sleeve did not easily slide into the 125 rad drill gde drop.This happened during use outside the patient; by hitting with a hammer, the sleeve attached to the drop.The procedure was completed with this device.10 minutes delay.No injury to patient.
 
Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Per the photo attached to the complaint, it confirms the locking pin is damaged causing the stated failure.A medical investigation was conducted and confirms per subsequent e-mail no relevant clinical information nor the device will be provided for inclusion in his medical investigation.Therefore, the root cause of the reported failure cannot be determined.It was reported this event happened during outside of the patient and by hitting using a hammer, the sleeve attached to the drop.Per communications, the same device was used to completed with a delay of 10 minutes.Since there was no injury reported to the patient, no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
125 RAD DRILL GDE DROP
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10738284
MDR Text Key213153280
Report Number1020279-2020-05779
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010570970
UDI-Public03596010570970
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,foreig
Type of Report Initial,Followup
Report Date 02/14/2021
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 Number71674002
Device Catalogue Number71674002
Device Lot Number12CM03678
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/26/2020
Supplement Dates Manufacturer Received02/11/2021
Supplement Dates FDA Received02/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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