MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFN BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Patient's birth year: 1953.This report is for an unk - nail head elements: pfn blade /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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2020 a patient underwent the surgery to treat the subtrochanteric femur fracture with a marrow nail osteosynthesis (synthes proximal femoral nail (pfn) alpha).The patient suffers from slow progressive arthrosis and requested the nail construct to be removed despite clinically low symptoms.Pre-operative information about a possible one-sided procedure in case of later necessity of hip replacement has been provided; nevertheless, the patient wanted the material to be removed to make a possible future tep treatment easier.Material removal was done on (b)(6) 2021.During the procedure it was easy to find the blade end in the thigh, insert the guide wire and completely expose the blade end of scar tissue.While doing the attachment of the extraction screw via the guide wire (anti-clockwise); the thread broke off in the blade end without significant force, therefore the extraction screwdriver could no longer be fastened.The material removal had then to be canceled.The nail and blade remained in the patient.No fragments were created.The surgeon suspects a cold weld of nail and blade.Patient outcome is reported as good.Concomitant device reported: combined hammer 500g f/03.010.170 (part# 03.010.170, lot# 8843406, qty 1).Unk - cable/wire (part# unknown, lot# unknown, qty1).This complaint involves three (3) devices.This report is for one (1) unk - nail head elements: pfn blade.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFN BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12656568
• MDR Text Key: 277147524
• Report Number: 8030965-2021-08772
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• 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
• Treatment: COMBINED HAMMER 500G F/03.010.170; EXTRACTSCR F/PFNA BLADE; UNK - CABLE/WIRE; UNK - NAILS: PFNA
• Patient Outcome(s): Required Intervention