MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT,FIXATION DEVICE CONDYLAR PLATE

Catalog Number	02.124.413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Event date: unknown when device broke.Additional product codes: hrs, hwc.Implant date: original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: unknown va locking screws (part #: unknown, lot #: unknown, qty.3), unknown full threaded cannulated conical screw (part #: unknown, lot #: unknown, qty.1), and unknown cortex screws (part #: unknown, lot #: unknown, qty.6).(b)(4).Device history records review was conducted.The report indicates that: dhr review for: part #: 02.124.413 / lot #: 8273487: manufacturing location: (b)(4).Manufacturing date: 30.Jan.2013.No 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.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 a patient was implanted with a 4.5mm variable angle (va) locking compression plate (lcp) curved condular 12 hole plate, three (3) va locking screws, one (1) 5.0mm full threaded cannulated conical screw, and six (6) 3.5mm cortex screws to repair a distal femur fracture on an unknown date.Postoperatively, on an unknown date, it was discovered that the plate had broken.On an unknown date, the patient was returned to the operating room to remove the broken device and implanted screws.The patient was reimplanted with a new plate and screws.It was confirmed that the patient was weight bearing against doctor's orders.This complaint involves one (1) device: 4.5mm va-lcp 12 hole plate with one part data.The procedure was completed successfully.Concomitant devices reported: unknown va locking screws (part #: unknown, lot #: unknown, qty.3), unknown full threaded cannulated conical screw (part #: unknown, lot #: unknown, qty.1), and unknown cortex screws (part #: unknown, lot #: unknown, qty.6).This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• Common Device Name: IMPLANT,FIXATION DEVICE CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6175585
• Report Number: 1000562954-2016-10228
• Device Sequence Number: 19081061
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873(10)8273487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 02.124.413
• Device Lot Number: 8273487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/15/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 100