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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. MEDIUM HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631066
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 08/30/2019
Event Type  Injury  
Event Description
It was reported that the capture in the medium hex driver broke. The device was inside the patient. The tip of the inner capture portion was lodged in the head of the screw that it connects to and was not able to be recovered.
 
Manufacturer Narrative
The associated complaint device was returned and evaluated. A visual inspection confirms the trigen medium hexdriver tip broke off into the screw. The screw was not returned for evaluation. Per the complaint description this piece could not be recovered. This instrument shows significant signs of use and wear. This device was manufactured in 2008. A clinical evaluation was conducted and based on the limited information provided the root cause of the tip of the inner capture portion breakage cannot be determined. However, based on the age of the device age related cannot be ruled out as a contributing factor. The 420/ 465 stainless steel are not implantable alloys; therefore, long-term implantation data is not available. The impact to the patient is the retained non-bio-inert fragment of the externally communicating device, additional radiological imaging/exposure, and although not likely since the tip is retained in the screw, possible micro-motion cannot be completely ruled out. No further clinical/medical investigation is warranted at this time. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary. Based on this investigation, the need for corrective action is not indicated. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. Should additional information be received, the complaint will be reopened.
 
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Brand NameMEDIUM HEXDRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9086881
MDR Text Key159147186
Report Number1020279-2019-03434
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71631066
Device Lot Number08LM01044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1
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