MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLARPLATE/14 HOLE/301MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.414

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a deformation of the thigh and a deformation of the femur following an osteosynthesis with a lcp plate implanted 2 months ago due to a fracture 1/3 inferior femur.No report of fall.A revision procedure was performed with removal of the plate and implantation of a new one.This report is for one (1) 4.5 mm va-lcp curved condylar plate / 14 hole /301 mm / right.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 02.124.414, lot: l112890, manufacturing site: mezzovico, release to warehouse date: september 20, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The received part was forwarded to manufacturing site for further investigation with the following results: returned items received not in original packaging.Information etched match to complaint system and device history record (dhr).The returned plate is bent and broken post production at level of the holes va-4,va-5, va-6.No evidence of visual nonconformance manufacturing related.The returned item has been manufactured and then released in september 2016 according to drawing.The involved lot, l112890, has been manufactured starting from the forging blank (material: stainless steel 1.4441 as per requirements).No nonconformances or document change have been identified which may be related to the complaint condition.The returned part was reinspected for all the features relevant to the complaint condition.The measurable features (thickness, width, and holes features) have been found conforming to manufacturing specifications.As per selected investigation flow flow, the investigations performed did not identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: code 3191 used to capture required surgical intervention and device removal.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLARPLATE/14 HOLE/301MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8932162
• MDR Text Key: 155869756
• Report Number: 8030965-2019-67733
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454101
• UDI-Public: (01)07611819454101
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414
• Device Lot Number: L112890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 09/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention