MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CURVED COND PL/10 HOLE/230/RT; SCREW, FIXATION, BONE

Model Number	02.124.410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent right distal femoral resection and endoprosthetic replacement/revision due to chronic right distal femur periprosthetic fracture nonunion and fractured lateral locking plate.This report is for one (1) 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device procode: hrs, jdp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is lawyer.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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: 4.5 VA-LCP CURVED COND PL/10 HOLE/230/RT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16724931
• Report Number: 8030965-2023-04524
• Device Sequence Number: 7949972
• Product Code: HWC
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: 02.124.410
• Device Catalogue Number: 02.124.410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/12/2023
• 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: 5.0 PERIPRO VAL SCR SLF-TPNG/SD/14.; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/14.; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/16.; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/18.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/20.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/26.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/32.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/36.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/38.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/40.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/46.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female