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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD PLATE TEMPLATES LEFT; PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. D-RAD PLATE TEMPLATES LEFT; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 71158017
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during an unspecified surgery, at the time of placing a locked screw in the most distal and external part of the d-rad plate templates left, it was completely inserted into the bone, when checking the plate it had a defect, it no longer had a star shape in the hole.However, it was ensured that the plate was locking correctly and the procedure was successfully completed with the same device.A delay less than or equal to 30mins was reported.No other complications were reported.
 
Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.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 the risk management file revealed this failure mode was previously identified.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 or product information, our investigation could not proceed.Should the device or 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
D-RAD PLATE TEMPLATES LEFT
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11135894
MDR Text Key225719831
Report Number1020279-2021-00192
Device Sequence Number1
Product Code HRS
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 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/17/2021
Device Catalogue Number71158017
Device Lot Number16EM14712
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/07/2021
Supplement Dates Manufacturer Received07/28/2021
Supplement Dates FDA Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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