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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 80/75; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 80/75; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 71677080
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event 03/25/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that following implantation of femoral nail for intertrochanteric fracture the lag screw is backing out about 5 mm but compression screw a lot.Fracture was being reduced well intra-op.Patient is doing fine with daily routine, no active sports activities, no pain.Due to no pain the surgeon did not take any actions and patient will be monitored.
 
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Brand Name
LAG/COMP SCREW KIT 80/75
Common Device Name
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6499653
Report Number1020279-2017-00272
Device Sequence Number16262370
Product Code JDS
UDI-Device Identifier03596010563286
UDI-Public03596010563286
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K040212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
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? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2025
Device Catalogue Number71677080
Device Lot Number15CT52970
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/25/2017
Supplement Date Received by Manufacturer03/25/2017
Initial Report FDA Received Date04/18/2017
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
INT HEX CAP SCR 5.0MM X 30MM, 71642230/16DM03706; INTERTAN 10S 10MM X 18CM 130D, 71675384/16HM20851
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