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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. DRILL GUIDE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674001
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
Event Type  malfunction  
Event Description
It was reported that, small pieces from a drill guide handle are cracking and falling off from it.No case reported; therefore, there was no patient involvement.
 
Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is cracked and missing pieces inside the handle along the seam.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.Should additional information be received, the complaints will be reopened.No further investigation is 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
DRILL GUIDE HANDLE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11610565
MDR Text Key243658500
Report Number1020279-2021-02594
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560469
UDI-Public03596010560469
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 06/26/2021
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 Number71674001
Device Catalogue Number71674001
Device Lot Number11KCL0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2021
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received06/24/2021
Supplement Dates FDA Received06/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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