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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFN LAG SCREW ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFN LAG SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Pma/510k: this report is for an unk - nail head elem: tfn lag screw/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 conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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: goodnough, l. H. Et al (2021), cephalomedullary helical blade is independently associated with less collapse in intertrochanteric femur fractures than lag screws, european journal of orthopedic surgery & traumatology, vol. Xx (xx), pages 1-5 (usa). The aim of this retrospective cohort study is to compare the effect of helical blades and lag screws on fracture site collapse after cephalomedullary fixation of intertrochanteric femur fractures. Between 2014 to 2020, a total of 171 patients treated with cephalomedullary nails with either lag screw or blade were included in the study. The cephalomedullary nails used were all tfn, tfna (synthes, paoli, pa), or competitor. A total of 129 patients (34 male and 95 females; mean age of 78. 2 ± 14. 0 years) in the blade group and 42 patients (12 male and 30 females; mean age of 81. 6 ± 10. 2 years) in the lag screw group. The median follow-up period was 6. 5 (3. 0¿53. 9) months and 4. 9 (3. 1¿56. 7) months for blade group and lag screw group, respectively. The following complications were reported: 3 additional patients, who did not have a follow-up at 3 months, had radiographic cut-out at the six-week mark. Blade group: the blade group had a collapse at the fracture site with a median of 4. 7 mm (iqr 2. 5¿7. 8). 19 patients demonstrated >10mm of shortening at the fracture site. 6 patients had radiographic cut-out. 13 patients underwent reoperation. 5 of which was due to cut-out. Lag screw group: the lag screw group had a collapse at the fracture site with a median of 8. 4 mm (3. 7-11. 2). 14 patients demonstrated >10mm of shortening at the fracture site. 2 patients had radiographic cut-out. 3 patients had reoperation. 2 of which was due to cut-out. This report is for an unknown synthes tfna helical blade, unknown synthes tfna lag screws, unknown synthes tfn helical blade, unknown synthes tfn lag screws, unknown synthes tfna constructs, and unknown synthes tfn constructs. This report is for (1) unk: nail head elem: tfna lag screw. This report is 8 of 14 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEM: TFN LAG SCREW
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 Key12345504
MDR Text Key267438708
Report Number2939274-2021-04746
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
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 Received07/21/2021
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: 08/19/2021 Patient Sequence Number: 1
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