MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown pfna construct/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.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: schuetze k., et al (2020) cement augmentation of the proximal femur nail antirotation: is it safe?, archives of orthopaedic and trauma surgery volume xxxxx, pages 1-9 (germany).This study aims to investigate the outcome and safety of augmentation of the proximal femur nail blade.Between january 2015 and december 2016, a total of 299 patients (94 men,205 women) aged 20¿102 (mean: 80; sd 13) with per- or subtrochanteric fractures were presented.All patients were treated with implantation of a proximal femoral nail antirotation with a perforated blade (fa.Depuy synthes) allowing augmentation with traumacem v+ cement (fa.Depuy synthes) were included.Cement augmentation was applied in 152 of 299 cases.Postoperative, 6-week, and 3-month follow up x-rays were reviewed.The following complications were reported as follows: 12 patients died during the hospital stay.Clinical records of 110 patients could be evaluated for the first postoperative year.In this time, 23 of the 110 patients died.(only the age of the patient showed a significant influence of hospital and 1-year mortality).Out of the 147 patients without augmentation, 21 needed an intervention in the second half of the operation or because of a blood pressure fall.17 cardiac events in the non-augmented and 22 in the augmented group were reported during the hospital stay.140 hypoxia > 94% and fall in systolic blood pressure < 20%.7 moderate hypoxia (< 94%) or hypotension (> 20%).The augmented group demonstrated a significant blood pressure fall shortly after augmentation (fig.3).115 hypoxia > 94% and fall in systolic blood pressure < 20%.36 moderate hypoxia (< 94%) or hypotension (> 20%).1 severe hypoxia (< 88%) or hypotension (> 40%).This report is for an unknown synthes proximal femoral nail antirotation with a perforated blade.It captures the reported adverse event in which out of the 147 patients without augmentation, 21 needed an intervention in the second half of the operation or because of a blood pressure fall.17 cardiac events in the non-augmented and 22 in the augmented group were reported during the hospital stay.140 hypoxia > 94% and fall in systolic blood pressure < 20%.7 moderate hypoxia (< 94%) or hypotension (> 20%).This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11408004
• MDR Text Key: 240728090
• Report Number: 8030965-2021-01585
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

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: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• 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