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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL 3.5MM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HUMERAL 3.5MM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71751140
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/22/2020
Event Type  malfunction  
Event Description
It was reported that the thumbscrew on hexdriver is broken off.No case involved.
 
Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed 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.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 complaint history did not reveal additional complaints for the listed batch.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, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
HUMERAL 3.5MM HEXDRIVER
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10849595
MDR Text Key216560256
Report Number1020279-2020-06510
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010515483
UDI-Public03596010515483
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,user f
Type of Report Initial,Followup
Report Date 05/07/2021
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 Health Professional
Device Model Number71751140
Device Catalogue Number71751140
Device Lot Number18DM04985
Initial Date Manufacturer Received 10/22/2020
Initial Date FDA Received11/16/2020
Supplement Dates Manufacturer Received04/26/2021
Supplement Dates FDA Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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