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

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna nail/ 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kim, s.J., park, h.S., lee, d.W., lee, j.W.(2019), short-term daily teriparatide improve postoperative functional outcome and fracture healing in unstable intertrochanteric fractures, injury, vol.50, pages 1364-1370, (south korea).The purpose of this study was to identify whether short-term daily teriparatide prescribed for osteoporosis treatment would improve postoperative outcomes including clinical scores, radiographic healing, and complication rates.Between march 2014 and august 2017, a total of 112 patients (42 males and 70 females) with an average age of the patients at the time of surgery was (b)(6) years (range, 66¿99 years) underwent reduction and internal fixation using a proximal femoral nail (proximal femoral nail anti-rotation, ao synthes).Patients were seen for follow-up at 4, 8, 12, 16, 20, and 24 weeks and then every 6 months thereafter.The following complications were reported as follows: a (b)(6) year-old patient had cutting-out of the lag screw from the femoral head occurred with varus collapse 3 months after surgery.However, the screw was remained because bony union was obtained and the patient had no symptoms.1 patient had loss of reduction 1 month post op.The patient was re-operated for cemnted bipolar hemiarthroplasty.1 patient had deep wound infection.11 patients had malunion.3 patients had superior cut-out of lag screw.3 patients had lateral screw migration requiring further intervention.Screws were exchanged because of severe skin irritation.2 patients had varus collapse with screw backout.They were reoperated for bipolar hip replacement.This report is for an unknown proximal femoral nail (proximal femoral nail anti-rotation, ao synthes).It captures the reported events of deep wound infection, malunion, loss of reduction.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• 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, PA 19380 ; 6103142063
• MDR Report Key: 9845513
• MDR Text Key: 194136128
• Report Number: 8030965-2020-02027
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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: 02/20/2020
• 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