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

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown dfn 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.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: d'sa, p.And karuppiah, s.V.(2019), extra articular distal femoral fractures in the elderly treated with retrograde nailing using a spiral-locking blade system, indian journal of orthopaedics, vol.53(2), pages 232-236 (united kingdom).This study was devised to look into the radiological outcome and complication rate in a series of elderly patients who were treated with retrograde nail using spiral locking blade system for extra articular distal femur fractures.From 2001 to 2015, a total of 41 patients (14 males and 27 females) with an average age of 80 years (range 70¿96 years) underwent retrogadrade nailing using a dfn (synthes, umkirch, germany).All patients were followed up until fracture union (clinical and radiological) with an average followup of 9 months (range 4¿18 months).A hinged-knee brace was used in eight patients for 6 weeks.The following complications were reported as follows: 4 patents had delayed union.1 patient was initially diagnosed with nonunion; however, without any further surgical intervention, the fracture united by 12 months.1 patient had superficial wound infection, which was successfully treated with antibiotics.3 patients had metal work protrusion below the intercondylar notch.1 patient had metal work protrusion below the intercondylar notch and was symptomatic with a painful knee; however, no revision surgery was done.This report is for a dfn nail (synthes, (b)(6)).This report captures the reported metal work protrusion.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - NAILS: DFN
• 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: 9770889
• MDR Text Key: 192727032
• Report Number: 8030965-2020-01543
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/19/2020

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: 02/19/2020
• Initial Date FDA Received: 02/28/2020
• 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