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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE,FIXATION,BONE Back to Search Results
Device Problem Bent (1059)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient information not available for reporting. This complaint captures 2 ((b)(6)) mechanical implant failure at the screw/plate interface. This report is for an unknown synthes 4. 5mm variable angle locking compression distal femur plate /unknown lot. Part and lot number are unknown; udi number is unknown. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Based on the information available, 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. [(b)(4) manuscript draft 16feb2018. Pdf].
 
Event Description
This report is being filed after the subsequent review of the following literature article draft dang k. H. , armstrong c. A. , karia r. A. , zelle b. A. (2018). Safety and efficacy of the synthes 4. 5 mm variable angle locking compression distal femur plate. Pp. 1-20. Usa. The purpose of this study was to examine the safety and efficacy of the synthes 4. 5 mm variable angle locking compression distal femur plate. The study included 74 patients (47 females & 27 males) all above the age of 18, who underwent open reduction and internal plate fixation of their acute distal femoral fracture using the synthes 4. 5mm variable angle locking compression distal femur plate. A total of 17 patients required reoperation to promote healing of the fracture. Of these 17 patients 3 experienced a septic nonunion and 14 experienced an aseptic nonunion. Seven (7) patients of the 74 (patient ids (b)(6)) experienced mechanical implant failures. Three (3) patients (patient ids (b)(6)) experienced postoperative breakage of the plate. Other medical complications include 1 valgus malunion, 3 deep vein thrombosis, 3 pulmonary emboli, 3 urinary tract infections, 2 pneumonias, 2 myocardial infarctions, 5 acute renal insufficiencies, 1 stroke and 1 upper gastrointestinal bleed. Lastly, in patient 15 the proximal screws were fractured at the plate/screw interface. One (b)(6) female patient (id unknown), who had been discharged after an uneventful postoperative course, was re-admitted to the hospital at 14 weeks after surgery with congestive heart failure. This patient deceased during her readmission. This is report 5 of 8 for (b)(4). This complaint involves unknown synthes 4. 5mm variable angle locking compression distal femur plate. One for 17 patients who needed reoperation, 3 patients who experienced septic nonunion, 14 patients who experienced aseptic nonunion, 1 patient who experienced valgus malunion, 3 patients who experienced deep vein thrombosis, 3 patients who experienced pulmonary emboli, 3 patients who experienced urinary tract infections, 2 patients who experienced pneumonias, 2 patients who experienced myocardial infarctions, 5 patients who experienced acute renal insufficiencies, 1 patient who experienced stroke and 1 patient who experienced upper gastrointestinal bleed. (these are all sis with no patient identifiers). One ((b)(6)) implant failure, postoperative breakage and revision surgery. One ((b)(6)) mechanical implant failure (the screws were discovered to be broken at the plate/screw interface). One ((b)(6)) mechanical implant failure, postoperative breakage and revision surgery. Two ((b)(6)) mechanical implant failure at the screw/plate interface. One ((b)(6)) mechanical implant failure (bent plate) and revision surgery due to dirt bike accident. One ((b)(6)) mechanical implant failure (plate bending), pain and deformity at fracture site due to a physical altercation. A revision surgery was required. One ((b)(6)) mechanical implant failure, postoperative breakage and required revision surgery. One for (b)(6) female patient who died after being readmitted in the hospital 14 weeks after the surgery with congestive heart failure.
 
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Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7282001
MDR Text Key100423464
Report Number2939274-2018-50673
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/20/2018 Patient Sequence Number: 1
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