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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 130 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 130 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674003
Device Problems Connection Problem (2900); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Event Description
It was reported that after an unspecified procedure, the drill guide handle was worn and was difficult to connect to the 130 rad drill gde drop.Procedure finished with same device.No surgical delay or injury to patient reported due this event.
 
Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The connector pins on the device were slightly bent preventing the device from functioning properly.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have 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.Should 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
130 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 Key11853770
MDR Text Key254824686
Report Number1020279-2021-04513
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560476
UDI-Public03596010560476
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 06/07/2021
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 No Information
Device Model Number71674003
Device Catalogue Number71674003
Device Lot Number14EM19883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2021
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received05/20/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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