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

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).

• Brand Name: UNK - NAIL HEAD ELEM: TFN LAG SCREW
• Type of Device: ROD, 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 Key: 12345504
• MDR Text Key: 267438708
• Report Number: 2939274-2021-04746
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention