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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.008.016S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that on january 6, 2021, the patient underwent a removal of titanium hindfoot arthrodesis cannulated nail due to nonunion.Procedure outcome is unknown.There was a patient consequence.This report is for one (1) 10mm ti hindfoot arthrodesis cann nail-ex 180mm/rt-sterile.This is report 2 of 5 for (b)(4).
 
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Brand Name
10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE
Common Device Name
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11240323
Report Number2939274-2021-00510
Device Sequence Number3927788
Product Code HSB
UDI-Device Identifier10886982087171
UDI-Public10886982087171
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K051678
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/06/2021
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? No
Operator of Device Health Professional
Device Model Number04.008.016S
Device Catalogue Number04.008.016S
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/06/2021
Initial Report FDA Received Date01/27/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEM NAIL; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
Outcome Attributed to Adverse Event Required Intervention;
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