MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT; PLATE,FIXATION,BONE

Model Number	02.124.406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of postoperative plate breakage is unknown.Additional device product codes: jdp, hwc.(therapy date): original surgery date (b)(6) 2017; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part # 02.124.406, lot # l343153: manufacturing location: (b)(4), manufacturing date: 24.Mar.2017: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 or Problem Description
It was reported that the patient had original surgery in (b)(6) 2017 for treatment of a right distal femur fracture.Patient was implanted with one (1) 4.5mm(va) variable angle locking compression curved condylar plate and eight (8) screws.Of the eight screws, one (1) 4.5mm cortex screw was implanted at the shaft on the plate, and seven (7) 5.0mm va locking screws were implanted in other plate hole screw positions.On an unknown date, post-operative, patient presented with a broken plate and one broken 4.5mm cortex screw.The plate was broken at the broken cortex screw position.On (b)(6) 2017, surgeon removed all implants and revised the patient to a longer va locking plate and screws.It was reported that all screws, the plate and any fragments were retrieved.All implants have been retained by the hospital.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.Concomitant devices reported:5.0mm va locking screws (part # unknown, lot # unknown, quantity 7) this report is for one (1) 4.5mm va-lcp curved condylar plate/6 hole/159mm/right this is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6915222
• Report Number: 1000562954-2017-10226
• Device Sequence Number: 1032674
• Product Code: HRS
• UDI-Device Identifier: 10886982042736
• UDI-Public: (01)10886982042736(10)L343153
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/18/2017

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 Model Number: 02.124.406
• Device Catalogue Number: 02.124.406
• Device Lot Number: L343153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/05/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 70