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

Catalog Number UNK - CONSTRUCTS: PFNA

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

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: hong c., (2017) the long and short of cephalomedullary nails in the treatment of osteoporotic pertrochanteric fracture, singapore med j volume 58(2) , pages 85-91 (singapore).This retrospective study aims to compare the complication rates and functional outcomes of treatment using long cephalomedullary nails with treatment using short cephalomedullary nails, for osteoporotic patients with ota class 31-a1 and class 31-a2 pertrochanteric fractures.From july 2009 to july 2012, all patients admitted for operative fixation of pertrochanteric fractures with cephalomedullary nailing at national university hospital, singapore, were reviewed.A total of 64 patients (45 female, 19 male) fulfilled the inclusion criteria of this study.Their mean age was 79.9 (range 5697) years and 38 of them had a left-sided hip injury a single implant design was utilized in our hospital: the proximal femoral nail anti-rotation (pfna) nail(synthes gmbh, oberdorf, switzerland).20 patients (14 females and 6 males) age 79.8 (5697 years ) were treated with long pfna nails and 44 ( 31 females and 13 males) age 80.0 (6093 years ) were treated with short pfna nails.The long nails were 320 mm (n = 1), 340 mm (n = 11) or 380 mm (n = 8) in length, while all short nails were 200 mm in length.Distal interlocking screws were used with both short and long pfna nails.Patients were reviewed two weeks after the operation for wound inspection and suture removal if needed.Subsequent reviews were at six weeks, and three, six and 12 months after the operation.Standard radiography of the hip was performed at these reviews.The following complications were reported as follows: in terms of mortality, two of the 64 patients died.One was an inpatient death due to ischaemic bowel, while the other was due to pneumonia after one year.1 deceased pre injury ambulatory status.Short nail: 5 heterotopic ossification.5 medialisation.1 lateral wall fracture.1 periprosthetic fracture.1 nonunion.1 wound infection.Cases required revision surgery: there were two cases of periprosthetic fractures (one case was revised to long nail and the other to cerclage wiring).One case of distal femur supracondylar fracture (distal plate and screw construct was done).An average drop of 2.2 (range 0.16.0) g/dl in hb level was observed in our study cohort.One case of nonunion with blade backout (the blade was consequently removed) (fig.1).Although the distal femur supracondylar fracture occurred several months after the operation via an accidental mechanical fall and was nowhere near the tip of the short nail, it was taken as a complication as well.This patient had a periprosthetic fracture at the tip of a short proximal femoral nail antirotation (pfna) nail.Long nail: 1 heterotopic ossification.2 medialisation.1 nonunion.An average drop of 2.2 (range 0.16.0) g/dl in hb level was observed in our study cohort.Cases requiring revision surgery: in the case involving a long nail, nonunion and blade backout was observed, and the patients surgery was revised to a bipolar hemiarthroplasty.This report is for an unknown synthes long pfna and short pfna.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA SHORT
• 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: 12554669
• MDR Text Key: 274044189
• Report Number: 8030965-2021-08157
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PFNA
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2021
• 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