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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS; SCREW,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS; SCREW,FIXATION,BONE Back to Search Results
Model Number 04.005.532
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 01/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2020, the patient had a proximal femur fracture that was treated with a trochanteric fixation nail advanced (tfna) on (b)(6) 2020, and the patient failed to heal.The surgeon decided to convert the patient to a total hip replacement surgery.Removal of the tfna was required to proceed with the desired procedure due to non-union.Procedure outcome is unknown.There was patient consequence.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 42mm for im nails.This is report 3 of 3 for (b)(4).
 
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Brand Name
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS
Common Device Name
SCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11214577
Report Number2939274-2021-00402
Device Sequence Number14201715
Product Code HWC
UDI-Device Identifier10886982086006
UDI-Public10886982086006
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K172157
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 12/24/2020
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 Number04.005.532
Device Catalogue Number04.005.532
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/24/2020
Initial Report FDA Received Date01/22/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
12MM/125 DEG TI CANN TFNA 380MM/RIGHT; TFNA FENESTRATED SCREW 90MM
Outcome Attributed to Adverse Event Required Intervention;
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