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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM X 42MM CORT BONE SCR ST SST PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. 4.5MM X 42MM CORT BONE SCR ST SST PLATE, FIXATION, BONE Back to Search Results
Model Number 3571129242
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  Injury  
Event Description

It was reported that, during a thr, two (2) 4. 5mm x 44mm cort bone scr st sst and two (2) 4. 5mm x 42mm cort bone scr st sst, were difficult to start insertion of a chs 4 hole 130 deg plate. Surgeon stated that the drill hole had been placed in freehand, therefore was too close to the plate for the screw to bite evenly. The procedure was completed with the same reported screws. However, it is unknown if there was a delayed or not. Patient was not injured as consequence of this problem.

 
Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed. A review of the 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. Possible causes could include but are not limited to alignment and procedural/user error or variance. 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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

 
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Brand Name4.5MM X 42MM CORT BONE SCR ST SST
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12233255
MDR Text Key263845679
Report Number1020279-2021-06044
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK993106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3571129242
Device Catalogue Number3571129242
Device LOT Number19KT28763
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/02/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/27/2021 Patient Sequence Number: 1
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