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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: AFN ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: AFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Non-union Bone Fracture (2369); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
510 k: this report is for an unk - constructs: afn/unknown lot. Part and lot numbers 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 as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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: hatem, m. Et al (2021), femoral derotation osteotomy improves hip and spine function in patients with increased or decreased femoral torsion, arthroscopy: the journal of arthroscopic and related surgery, vol 37 (1), pages 111-123 (usa). The aim of this retrospective study is to evaluate the outcomes of proximal femoral derotation osteotomy (pfdo) on the hip and spine function of patients with abnormal femoral torsion. Between july 2014 to february 2019, a total of 34 patients (37 hips; 8 male and 26 female) with an average age of 33 years (range, 15-54 years) underwent proximal femoral derotation osteotomy (pfdo). Surgery was performed using an anterograde femoral nail (femoral nail, synthes, west chester, pa). The mean follow-up was 24 months (range, 12-65 months). The following complications were reported: 1 patient with increased femoral torsion and ehlers danlos syndrome underwent a second pfdo at the same hip at 28 months after the primary pfdo because of a lack of clinical improvement and lack of femoral torsion correction. 2 patients had a nonunion of the osteotomy site. A revision procedure with a larger intramedullary nail allowed the consolidation of the osteotomy in both patients. 1 patient was observed to have a delayed union in one femur and was successfully treated with locking screw removal at 6 months after the pfdo. In 4 hips, a nonsymptomatic grade 1 heterotopic ossification was observed at the entrance point of the femoral nail at the most recent radiographic examination. This report is for an unknown synthes afn constructs. This report is for (1) unk - constructs: afn. This is report 1 of 1 (b)(4).
 
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Brand NameUNK - CONSTRUCTS: AFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11367258
MDR Text Key241766050
Report Number2939274-2021-01026
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
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