MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CURVED COND PL/6 HOLE/159/LFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.407

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.E3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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

It was reported that on an unknown date intraoperatively during a distal femur, locking tower stripped the va condylar hole.The plate was not billed to patient.During the same surgery during an orif patella procedure locking tower did not thread into plate, so it was not billed to patient either.It was unsure if it was due to bending of plate.There was no patient consequences.This report is for one (1) 4.3mm threaded lcp(tm) drill guide.This is report 3 of 5 for complaint.

• Brand Name: 4.5 VA-LCP CURVED COND PL/6 HOLE/159/LFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18480359
• MDR Text Key: 332740149
• Report Number: 8030965-2024-00520
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042750
• UDI-Public: (01)10886982042750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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: 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP.; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP.; 4.3MM THREADED LCP(TM) DRILL GUIDE.; VA LOCK PATELLA PL 2.7 ANT CORE SM SST.