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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR.BIORCI REV THRD 7X25MM (8MM HEAD); SCREW, FIXATION, BONE

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SMITH & NEPHEW, INC. SCR.BIORCI REV THRD 7X25MM (8MM HEAD); SCREW, FIXATION, BONE Back to Search Results
Model Number 7207607
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  malfunction  
Event Description
It was reported that the screw was found disintegrated when it was trying to screw it in.No patient injury reported.
 
Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.A review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.
 
Manufacturer Narrative
One 7x25mm biorci reverse thread screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 5mm of the distal threads have broken off.The broken portion was returned in three pieces of varying sizes.Dimensional assessment of the screws major diameters and wall thickness was performed and found to be within print specifications.Due to the limited clinical details provided we are unable to provide a root cause for this failure.This investigation could not identify any evidence of product contribution to the reported complaint.
 
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Brand Name
SCR.BIORCI REV THRD 7X25MM (8MM HEAD)
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7227652
MDR Text Key98738934
Report Number1219602-2018-00170
Device Sequence Number1
Product Code HWC
UDI-Device Identifier03596010426307
UDI-Public(01)03596010426307(17)190918(10)50520253
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K992396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/05/2018
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 Expiration Date09/18/2019
Device Model Number7207607
Device Catalogue Number7207607
Device Lot Number50520253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2018
Initial Date FDA Received01/30/2018
Supplement Dates Manufacturer Received01/19/2018
06/04/2018
Supplement Dates FDA Received03/02/2018
06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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