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

Catalog Number 02.124.416S

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procodes: hrs, hwc.Date of implantation is reported to be an unknown date in late (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is the same as date of implantation, an unknown date in late (b)(6) 2018.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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.

Event Description

Device report from the (b)(6) reports an event as follows: it was reported that during a fixation of the distal femur in (b)(6) 2018, the patient was implanted with one (1) variable angle (va) locking compression plate (lcp) condylar plate, three (3) stardrive va locking screws, and two (2) self-tapping cortex screws.About 6-7 weeks ago, the plate started to bend.This was confirmed on x-ray on an unknown date.The patient has been weight bearing on the leg.There are currently no plans for revision.Concomitant devices: cortex screw (part: 214.848s, lot: l430555, quantity: 1); cortex screw (part: 214.836s, lot: l967243, quantity: 1); va locking screw (part: 02.231.275s, lot: 1l82474, quantity: 1); va locking screw (part: 02.231.275s, lot: 2l13298, quantity: 1); va locking screw (part: 02.231.280s, lot: l648063, quantity: 1).This report is for a 4.5mm va-lcp curved condylar plate.This is report 1 of 1 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.The received x-rays were reviewed, there is on the last two x-rays a deformation of the plate in the fracture region visible.The manufacturing documents were reviewed and no complaint related issues were found.The risk management file was reviewed and it was found that this complaint condition is adequately addressed.Product was not returned, therefore no further investigation is possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot, part: 02.124.416s, lot: 1l24619, manufacturing site: mezzovico, release to warehouse date: 11.Sep.2018, expiry date: 01.Sep.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 CONDYLAR PLATE/16HOLE/336MM/RT-STER
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8412056
• MDR Text Key: 138521131
• Report Number: 8030965-2019-61892
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455948
• UDI-Public: (01)07611819455948
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416S
• Device Lot Number: 1L24619
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90