MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: TFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved in the study.Implantation date unknown.This report is for an unk - constructs: tfn/ 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 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.(b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hoffmann mf, khoriaty jd, sietsema dl, jones cb (2019), outcome of intramedullary nailing treatment for intertrochanteric femoral fractures, journal of orthopedic surgery and research, volume 14, page 1-7, germany.The purpose of this study was to evaluate a series of intramedullary nail treatment of intertrochanteric femoral fractures (type 31 a3 according to the ota/ao-classification) in regard to surgical procedure, complications, and clinical outcome.Between 2004 and 2013, 193 intertrochanteric femoral fractures in 193 patients with a mean age of 70.2 years (range 19¿96 years) were included in the study.There were 80 males and 113 females with an average body mass index (bmi) of 26.7 kg/m2 (range 15.6¿54.7 kg/m2).Different nailing systems and implant materials were used.A total of 4 patients were implanted with an unknown synthes trochanteric fixation nail system while the rest of the patients were implanted with competitors¿ devices.Patients were evaluated at regular and consistent intervals of 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years or until bone healing was radiographically present.The length of follow-up was 15.2 months (range 6¿97) with a median of 11.5 months.The authors did not specify which patients were implanted with the synthes device.Thus, complications will be reported as follows: 48 patients had secondary surgery.8 patients had fixation failure and were revised.12 patients had nonunion with additional 6 fractures resulting in a malunion.2 patients had infection and hematoma.17 patients had painful hardware leading to hardware removal.2 patients had avascular necrosis of the femoral head and were converted into total hip arthroplasty.6 patients had malunion.1 patient had heterotopic ossifications.6 patients had varus alignment.3 patients had valgus alignment.26 patients had leg length discrepancy.84 patients had a persistent mean pain level of 3.6.Most patients had reduced hip range of motion.This report is for an unknown synthes trochanteric fixation nail system.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9891644
• MDR Text Key: 194771235
• Report Number: 8030965-2020-02373
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• 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
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention