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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown plate/screws constructs/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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 Description

This report is being filed after the review of the following journal article: hussain, m. , kakazu, r. , jimenez, a. , and wyrick, j. (2020), proximal cortical breach after retrograde femoral nailing for femoral shaft fracture. A case report, jbjs case connect, vol. 10 (1), pages 1¿5 (usa). This study presents a case report of a (b)(6) year-old male patient who sustained a comminuted, distal diaphyseal femoral shaft fracture (ao/ota 32b1) was treated with retrograde nailing. It was complicated by proximal cortical breach. The proximal fracture was detected intraoperatively and treated with plating. A 9-hole synthes less invasive stabilization system (liss) plate was chosen to buttress the fracture fragment while avoiding extensive soft-tissue dissection (fig. 2-e). Postoperatively, the patient ambulated with weight of leg foot flat restrictions. His medical complications including delirium and acute kidney injury were managed medically, and he was discharged to a rehabilitation facility. He gradually advanced his weight-bearing, walking with a cane at 6 weeks postoperative. By 4 months, the patient had returned to work and was able to walk with a slight limp without assistive devices. Radiographs at 8 months postoperative demonstrate healing of both fractures, proximal and distal (figs. 3-a through 3-d). At the latest follow-up, a discussion was made regarding the removal of the proximal plate on an elective basis because of irritation at the hip from the liss plate. This report is for an unknown synthes plate/screws constructs. This is report 1 of 1 for (b)(4).

 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10742283
MDR Text Key213397622
Report Number2939274-2020-04838
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/27/2020 Patient Sequence Number: 1
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