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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD SMART PACK 4H RIGHT WIDE PLATE; PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. D-RAD SMART PACK 4H RIGHT WIDE PLATE; PLATE, FIXATION, BONE Back to Search Results
Model Number 71158022
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference number: (b)(4).
 
Event Description
It was reported that during surgery, it was noticed that the screwdriver in the sterile kit showed traces of rust.The procedure was completed using another smith & nephew device with no surgical delay, and no injury to the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The device, used 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential probable causes for this event could include damaged product, implant corrosion or wear.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.A relationship, if any, between the device and the reported incident could not be corroborated.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.We consider this investigation closed.
 
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Brand Name
D-RAD SMART PACK 4H RIGHT WIDE PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11390981
MDR Text Key233948074
Report Number1020279-2021-01646
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00885556364598
UDI-Public00885556364598
Combination Product (y/n)N
PMA/PMN Number
K132296
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71158022
Device Catalogue Number71158022
Device Lot NumberUNKNOWN
Date Manufacturer Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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