MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.417S

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown if plate was broken before the fall.Additional product codes: hrs, hwc.Original surgery performed sometime in (b)(6) 2015.(b)(6).Subject device has not been received.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 received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows it was reported that a revision left distal femur peri prosthetic fracture performed on (b)(6) 2016 by dr (b)(6) at (b)(6) hospital.Patient underwent a revision of left distal femur peri prosthetic fracture following a fall down the stairs and landing on his left leg.Plate broke at the original fracture site.Original surgery performed (b)(6) 2015.No further information is available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

(b)(4).Dhr review - 02.124.417s ¿ 9409850.Manufacturing site: (b)(4).Manufacturing date: 09.Apr.2015.Expiry date: 01.Mar.2025.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.Corrected data: catalog number.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.

Manufacturer Narrative

Manufacturing investigation evaluation: the plate received together with ten (10) intact screws.The reference numbers etched match with complaint references.The plate is broken into two (2) pieces.The returned plate was re-inspected for all the features pertinent to the complaint condition.The plate is broken at the level of hole number 4.The holes close to the fracture were re-inspected and found to be conforming to specifications.Also, the plate thickness was within specification.Since the shaft and the holes are manufactured in the same production step, using the same cnc program and tools, it is possible to conclude that the plate was conforming to specifications at the level of the fracture.Considering that all relevant measurable product features meet specifications, and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.The complaint is, therefore, disposed as confirmed due to evidence that plate is broken.However, it is not considered valid for (b)(4) because there is no evidence of issues that were manufacturing related.It is most likely that this breakage happened as the patient fell down the stairs, landing on the left leg.Device 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5477136
• MDR Text Key: 39584467
• Report Number: 2520274-2016-11444
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.417S
• Device Lot Number: 9409850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention