MAUDE Adverse Event Report: SYNTHES GMBH 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/LARGE/10HOLES/RIGHT; PLATE, FIXATION, BONE

Catalog Number	02.221.094
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on (b)(6), 2023 during an unknown procedure, while performing a periprosthetic fracture orif and after placing two cables, the surgeon noticed that two of the cables were looser than anticipated.They decided that it was more due to technique and cut the cables out, and placed two new ones to reduce the fracture.Sales rep let the surgeon know the minimum fixation recommendations of two cables proximally in this type of fracture.They chose to only use one cable and accepted it.While using the ppfx proximal femur system, the surgeon said the plate did not properly fit the patient's contour and the distal spanning plate was not properly designed to fit the distal femur condyle.The proximal femur ppfx was bent distally and the surgery was successfully completed.During the surgery they also needed a 70mm 5mm va locking, however the set was only sent with screws up to 60mm which surgeon had to use.Surgery was completed successfully with a delay of ten (10) minutes.This report is for one (1) 3.5/4.5mm va ppfx prox femur hook pl/large/10holes/right this is report 1 of 2 for complaint (b)(4).

• Brand Name: 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/LARGE/10HOLES/RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17655585
• Report Number: 8030965-2023-10985
• Device Sequence Number: 6313572
• Product Code: HRS
• UDI-Device Identifier: 10886982275615
• UDI-Public: (01)10886982275615
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.221.094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.7MM CABLE WITH CRIMP 750MM-STERILE; 1.7MM CABLE WITH CRIMP 750MM-STERILE; 3.5 VAL DSTL FEM SPAN ATCH PL/4H/STD/RT; UNK - SCREWS: VA LOCKING
• Patient Sex: Female