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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 04/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A revision was reported due to the fact that the patient was experiencing pain and it was believed that the fracture could have been gapping.After revision, the doctor concluded that it was most likely to have happened due to patient's bone quality.
 
Additional Manufacturer Narrative
(b)(4).
 
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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 road
memphis TN 38116
MDR Report Key6556334
Report Number1020279-2017-00331
Device Sequence Number10786882
Product Code JDS
UDI-Device Identifier03596010563316
UDI-Public03596010563316
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K040212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/03/2017
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 Model Number71677095
Device Catalogue Number71677095
Device Lot Number17BT82868
Was Device Available for Evaluation? No
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 Date10/03/2017
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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