MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.265

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: hrs, hwc.(b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient initially underwent surgery on (b)(6) 2017 for a right distal femur fracture and was implanted with a 4.5mm locking compression plate (lcp) plate and 9 locking screws.During a post-operative visit, date unknown, an x-ray revealed a nonunion and that four screws were backing out of the plate.The patient was returned to the operating room on (b)(6) 2017 for the removal of the plate and nine screws and revision to a new lcp condylar plate and seven screws.It was reported that the devices were intact and easily removed.During the revision surgery the non-union site was reduced and new lcp condylar plate and seven screws were implanted.There was no delay in surgery and the patient was reported as stable.Concomitant devices: 4.5mm va-lcp curved condylar plate/6 hole/159mm/left (part# 02.124.407, lot# unknown, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/20mm (part #02.231.220, lot #unknown, quantity 2), 5.0mm variable angle lockng screw/slf-tpng/strdrv/40mm (part #02.231.240, lot #unknown, quantity 2) and 5.0mm variable angle lockng screw/slf-tpng/strdrv/60mm (02.231.260, lot #unknown, quantity 1).This report is for one (1) 5.0mm variable angle lockng screw/ slf-tpng/strdrv/65mm.This is report 1 of 4 for complaint (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6653408
• MDR Text Key: 78018288
• Report Number: 1000562954-2017-10100
• Device Sequence Number: 1
• Product Code: JDP
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 102