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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 95/90; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 95/90; NAIL, FIXATION, BONE Back to Search Results
Model Number 71677095
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/19/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery on (b)(6) 2021, a intertan 10s 10mm x 40cm 125d left and a intertan lag/compression screw kit 95mm / 90mm broke.A revision surgery was performed on (b)(6) 2021 to remove it and insert a new one.Current health status of the patient is unknown.
 
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Brand Name
LAG/COMP SCREW KIT 95/90
Common Device Name
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12453261
Report Number1020279-2021-06789
Device Sequence Number5360438
Product Code JDS
UDI-Device Identifier03596010563316
UDI-Public03596010563316
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K040212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/21/2021
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 Number71677095
Device Catalogue Number71677095
Device Lot Number20GT39866
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/19/2021
Supplement Date Received by Manufacturer10/20/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/21/2021
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 Hospitalization; Required Intervention;
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