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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL IMPL; NAIL, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL IMPL; NAIL, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Date 02/01/2023
Event Type  Injury  
Event Description
It was reported that on literature review "effects of interlocking intramedullary nail internal fixation on hss and aofas scores in patients with extra-articular distal tibial fractures", 1 (one) patient suffered from a fracture malunion after having an interlocking intramedullary nail internal fixation (trigen meta-nail) treatment for an extra articular distal tibial fracture.It is unknown if or how the adverse event was treated.The outcome of the patient is unknown.No further information is available.
 
Manufacturer Narrative
Feng gang, han weijie & ai tianfeng.(2023).*effects of interlocking intramedullary nail internal fixation on hss and aofas scores in patients with extra-articular distal tibial fractures.Clinical medical research and practice.10.19347/j.Cnki.2096-1413.202304015.Internal reference: case (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
 
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Brand Name
UNKN TRIGEN ANTEGR TIB/RETROGR FEM NAIL IMPL
Type of Device
NAIL, 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 Key16865018
MDR Text Key314524950
Report Number1020279-2023-00925
Device Sequence Number1
Product Code JDS
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
Reporter Occupation Physician
Type of Report Initial
Report Date 05/03/2023
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? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2023
Initial Date FDA Received05/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Disability; Other;
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