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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 71934479
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Code Available (3191)
Date of Event 04/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the intertan broke four and a half months out.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
INTERTAN 10MM X 24CM 125D
Common Device Name
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6556342
Report Number1020279-2017-00332
Device Sequence Number614198
Product Code JDS
UDI-Device Identifier00885556105092
UDI-Public00885556105092
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K040212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/19/2017
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
Operator of Device Health Professional
Device Expiration Date08/09/2026
Device Catalogue Number71934479
Device Lot Number16HM08425
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2017
Initial Date Received by Manufacturer 04/13/2017
Supplement Date Received by Manufacturer04/13/2017
Initial Report FDA Received Date05/10/2017
Supplement Report FDA Received Date09/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
LAG/COM SCREW KIT 110/105, 71677110/15ET54707; LOW PROF. SCREW 5.0MMX32.5MM, 71645032/15MT62528
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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