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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 10H 133MM; PLATE, FIXATION, BONE
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SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 10H 133MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 71829010
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 03/23/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during follow up 3/23/17 patient complained of pain and surgeon noticed the broken plate.Revision surgery was performed and a broken plate was removed.
 
Additional Manufacturer Narrative
Please see attached file for the results of our investigation.(b)(4).
 
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Brand Name
3.5MM LCK TUBULAR PL 10H 133MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6652953
Report Number1020279-2017-00445
Device Sequence Number1285932
Product Code HRS
UDI-Device Identifier03596010525581
UDI-Public03596010525581
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K033669
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 09/28/2017
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 Number71829010
Device Catalogue Number71829010
Device Lot Number15HT58167
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 05/23/2017
Supplement Date Received by Manufacturer07/10/2017
07/10/2017
Initial Report FDA Received Date06/20/2017
Supplement Report FDA Received Date07/10/2017
09/29/2017
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;
Patient Age28 YR
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