MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: FEMORAL; PLATE, FIXATION, BONE

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the unknown proximal femoral plate broke and caused the fracture to be poorly reduced.The screw configuration was too dense for the type of fracture.The plate was replaced for a ppfx plate on (b)(6) 2022.The implant has been in the patient for around 10 weeks.The surgeon stated that the plate was probably too short for the fracture pattern.No further information was provided.This report is for one (1) unknown proximal femoral plate.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown proximal femoral plate/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 expected to be returned for manufacturer review/investigation, but has yet to be received.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.

• Brand Name: UNK - PLATES: FEMORAL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13740681
• MDR Text Key: 287140878
• Report Number: 8030965-2022-01569
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/11/2022
• 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 - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 7.3 MM CANNULATED
• Patient Outcome(s): Required Intervention
• Patient Sex: Male