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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/LEFT/86MM; PLATE, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/LEFT/86MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 04.112.139
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Skin Irritation (2076)
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 (b)(6) 2020, the patient underwent a hardware removal of titanium locking compression plate lateral distal fibula plate 4h/left because of skin irritation and possible infection.The surgeon removed 5 unknown length titanium 2.7 locking screws, 1 unknown length 3.5 cortex screw, and 2 unknown length 3.5 locking screws.Patient also had an arthrex tightrope removed.Upon removal, the fracture appeared healed to the surgeon and there was no visible infection.Procedure was completed successfully.Patient status and outcome was good and fracture appeared to be healed.This is report 1 of 9 for (b)(4).
 
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Brand Name
2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/LEFT/86MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10069460
Report Number2939274-2020-02394
Device Sequence Number3696791
Product Code HRS
UDI-Device Identifier10886982103604
UDI-Public(01)10886982103604
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K083213
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/06/2020
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 Number04.112.139
Device Catalogue Number04.112.139
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/06/2020
Initial Report FDA Received Date05/19/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
Outcome Attributed to Adverse Event Required Intervention;
Patient Age17 YR
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