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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW NAIL, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW NAIL, FIXATION, BONE Back to Search Results
Catalog Number UNKN02100106
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Non-union Bone Fracture (2369)
Event Date 03/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after a trigen intertan system was implanted on plaintiff left femur on (b)(6) 2018, the plaintiff experienced increased pain on left knee. By x-rays, failure of the distal locking screws and distal migration of the tip of the nail were found. A revision surgery was performed on (b)(6) 2019 to treat these adverse events. During surgery, it was found that the proximal ends of 2 distal locking screws were broken. The trigen intertan components were explanted. The patient outcome is unknown.
 
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Brand NameUNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW
Type of DeviceNAIL, 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 Key12523562
MDR Text Key273075367
Report Number1020279-2021-07101
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/24/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN02100106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? No
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: 09/23/2021 Patient Sequence Number: 1
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