MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This patient¿s information is not available.Date of postoperative necrosis development is unknown.This report is for an unknown tfna nail/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for tfna nail is not provided.(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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017 a patient underwent for the surgery to treat the subtrochanteric fracture and was implanted with trochanteric femoral nail-antirotation (tfna) system.On an unknown postoperative date, the patient visited the hospital because patient felt a pain.It was found under the x-ray that necrosis of the femoral head had occurred while the bone union was observed.On (b)(6) 2018, the revision surgery is scheduled to extract the tfna implants and apply the bipolar hip arthroplasty (bha).The surgeon does not know what caused this event because the patient had not taken any special medications.Concomitant devices reported: nail head elements: screw (part # unknown, lot # unknown, quantity 1), end caps: tfna (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown tfna nail.This is report 1 of 2 for complaint (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7636342
• MDR Text Key: 112276115
• Report Number: 8030965-2018-54610
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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: 05/31/2018
• 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
• Patient Age: 83 YR