MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA SHORT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna blade/unknown lot.Part and lot number 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.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 (b)(6) reports an event as follows: it was reported that about five (5) years ago, on unknown date, the patient underwent the surgery for trochanteric femur fracture with the (b)(6) pfna blade.After the surgery, on unknown date, the device cut-out occurred.The trochanteric fracture part was fused without any problem.The patient fell and had a subcapital fracture and cut-out.The surgeon considered that this event could be managed by removing the blade alone.The surgeon will remove only the blade without replacing the artificial head in the reoperation.The surgeon considers that the cut-out was not caused by the blade but indirectly caused by a fall.No further information is available.This report is for a pfna blade.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA SHORT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12238763
• MDR Text Key: 263863044
• Report Number: 8030965-2021-06137
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 06/30/2021
• 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: UNK - END CAPS: PFNA; UNK - NAILS: PFNA; UNK - SCREWS: PFNA
• Patient Outcome(s): Required Intervention