MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CURVED COND PL/16 HOLE/336/RT; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.416

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023 during a procedure there was a inter-prosthetic fracture with a distal femur fracture.A frn was inserted and then two plates were inserted distally.A lateral plate was inserted and the same plate, but contralateral side was put on the medial side.During the frn, the proximal portion became snagged up.The drive cap broke during malleating.While inserting both plates distally, the center hole did not lock into the plate.Unsure if it was due to the traffic of the screws, and making the screws skive off axis.Depth gauge was also bent in the process of measuring for screws.There were four (4) minutes of surgical delay.This complaint involves five (5) device.This report is for one (1) 4.5 va-lcp curved cond pl/16 hole/336/rt this is report 2 of 5 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: additional pro-codes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.

• Brand Name: 4.5 VA-LCP CURVED COND PL/16 HOLE/336/RT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 16649229
• MDR Text Key: 312875072
• Report Number: 8030965-2023-03898
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• 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: 4.5 VA-LCP CURVED COND PL/6 HOLE/159/LFT; CONNEC F/INSERTION HANDLE F/PFNA; CONNEC F/INSERTION HANDLE F/PFNA; DEPTH GAUGE FOR LCKNG SCRS TO 100