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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 13MM X 20CM 125D; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. INTERTAN 13MM X 20CM 125D; NAIL, FIXATION, BONE Back to Search Results
Model Number 71675206
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/13/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2020, post-op x-rays showed that the lag/comp screw kit 105/100 of an intertan 13mm x 20cm 125d nail are backing out, despite being locked in the case.It is unknown how this adverse event was solved.Current health status of patient is also unknown.
 
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Brand Name
INTERTAN 13MM X 20CM 125D
Common Device Name
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12388784
Report Number1020279-2021-06616
Device Sequence Number3576972
Product Code JDS
UDI-Device Identifier03596010572103
UDI-Public03596010572103
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K040212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/15/2021
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? Yes
Operator of Device Health Professional
Device Model Number71675206
Device Catalogue Number71675206
Device Lot Number18JT09926
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/13/2021
Supplement Date Received by Manufacturer10/14/2021
Initial Report FDA Received Date08/30/2021
Supplement Report FDA Received Date10/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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