MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/4H LNG/RIGHT; PLATE, FIXATION, BONE

Catalog Number	02.221.152
Medical Device Problem Code	Defective Device (2588)
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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) 3.5mm va ppfx dstl femur span attchmt pl/4h lng/right.This is report 2 of 2 for complaint (b)(4).
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.H3, h4, h6: part 02.221.152, lot 882p770: manufacturing site: mezzovico.Release to warehouse date: july 27, 2022.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances related to the malfunction were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that there was no damage or defects.A dimensional inspection was performed and met specifications.The current and manufactured to drawings were reviewed.The overall complaint was not confirmed as the plate was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.
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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/4H LNG/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: 17655586
• Report Number: 8030965-2023-10986
• Device Sequence Number: 6313573
• Product Code: HRS
• UDI-Device Identifier: 10886982276520
• UDI-Public: (01)10886982276520
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 02.221.152
• Device Lot Number: 882P770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 12/07/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/14/2023; 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• 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; 3.5/4.5 VA PROX FEMUR HOOK PL/LRG/360/RT; UNK - SCREWS: VA LOCKING
• Patient Sex: Female