MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; PLATE,FIXATION,BONE

Catalog Number	02.124.411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: therapy date is unknown.Screws - mix of cortical and locking screws (quantity# 10 to 12).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent revision surgery due to a broken plate.The plate was originally implanted months earlier at another institution and consisted of a 4.5 mm variable angle (va) locking compression plate (lcp) curved condylar plate/ 10 hole/ 230 mm/ left and ten (10) to twelve (12) screws (mix of cortical and locking screws).It was reported that the plate broke into two (2) clean pieces.The plate and all screws were removed and the patient was revised to a femoral nail.The surgery was reported to be successfully completed.Patient outcome is unknown since the hospital did not wish to share any patient information.This complaint involves one (1) device.Concomitant devices reported: screws - mix of cortical and locking screws (part# unknown, lot# unknown, quantity# 10 to 12).This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 7020559
• Report Number: 1000562954-2017-10246
• Device Sequence Number: 1612939
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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 Catalogue Number: 02.124.411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention