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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN CANNULATED SCREWS SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. UNKNOWN CANNULATED SCREWS SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
On the literature article named "tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients", it was reported that, after cannulated screws screw had been implanted on 3 patients, after conventional internal fixation surgery using three 7. 3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, 3 patients reported delayed fracture union in a time frame of 4-8 months postoperatively, which later developed in avascular necrosis of the femoral head. Further details on how was this adverse event treated are unknown.
 
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Brand NameUNKNOWN CANNULATED SCREWS SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key12615821
MDR Text Key275909053
Report Number1020279-2021-07532
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/12/2021 Patient Sequence Number: 1
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