MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; 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 report is for an unknown nail head elements: fns anti-rotation.Part and lot numbers are unknown; udi 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.(b)(4).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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent the open reduction internal fixation (orif) surgery for medial femoral neck fractures by using fns implants.It is unknown how the surgery was finished.On an unknown date, the surgeon confirmed that the position after reduction had collapsed due to femoral head necrosis.On an unknown date, re-surgery was performed, in which the fns implants in use were removed.No further information is available.Concomitant devices: unk - plates: fns (part number unknown, lot number unknown, quantity 1), unk - nail head elements: fns bolt (part number unknown, lot number unknown, quantity 1), unk - screws: locking (part number unknown, lot number unknown, quantity 1) this report is for one (1) unk - nail head elements: fns anti-rotation.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
• 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 ; 6107195000
• MDR Report Key: 10053541
• MDR Text Key: 196806306
• Report Number: 8030965-2020-03476
• 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: 04/30/2020

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: 04/30/2020
• Initial Date FDA Received: 05/13/2020
• 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
• Patient Age: 72 YR