MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.412

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Additional procode: hrs, hwc.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had previously undergone procedure for comminuted subtrochanteric fracture of the left femur osteosynthesis with a plate which failed due to breakage.This caused the patient to fracture again.This plate was from another provider.The patient underwent revision surgery on (b)(6) 2021 and the surgeon placed a 4.5mm va-lcp curved condylar plate.There was no surgical delay.The procedure was successfully completed.Fragments were generated and easily removed from the patient without additional intervention.There was no patient consequence.This report is for one (1) 4.5mm va-lcp curved condylar plate/12 hole/266mm/right.This is report 1 of 1 for (b)(4).

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 02.124.412, lot 48p0002: manufacturing site: mezzovico.Release to warehouse date: may 06, 2020.A manufacturing record evaluation was performed for the not sterile lot number.No manufacturing irregularities related to the malfunction were identified.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12289192
• MDR Text Key: 265441400
• Report Number: 8030965-2021-06486
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454088
• UDI-Public: (01)07611819454088
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Device Lot Number: 48P0002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1
• Treatment: 5.0 CANNULATED VA LCK SCRW/60; 5.0 CANNULATED VA LCK SCRW/80; 5.0 CANNULATED VA LCK SCRW/85; CANNSCR Ø5 L80 SST; VA LOCKSCR Ø5 SELF-TAP L60
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 75