MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/10HOLE/230MM/LT-STER; IMPLANT,FIXATION DEVICE CONDYLAR PLATE

Catalog Number 02.124.411S

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product codes: hrs, hwc.A review of the device history records has been requested.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent hardware removal on (b)(6) 2018 due to failed variable-angle locking compression plate (va-lcp) and possible infection issue.Explanted implants are as follows: one (1) 4.5mm variable angle curved condylar plate (va-lcp), one (1) locking screw 60mm, three (3) locking screw 65mm, one (1) locking screw 36mm, and three (3) locking screw 30mm.Original implant date is unknown.It is unknown if the procedure was completed successfully.There was no surgical delay noted.Patient outcome is unknown.This complaint involves nine (9) devices.This report is for 1 variable-angle locking compression plate.This report is 1 of 9 for (b)(4).

Manufacturer Narrative

Part: 02.124.411s.Lot: l694970.Manufacturing site: (b)(4).Release to warehouse date: 03.Jan.2018.Expiry date: 01.Dec.2027.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The visual inspection has shown that the thread flanks of the locking holes are slightly worn.Also, there are scratches on the surface of the plate visible.All damages can be traced back to the insertion and/or extraction of the screws.Summary: the plate in question was returned without specific allegation, the description just states failed.The visual inspection did not identify any unexpected damage, which could have caused a malfunction of the plate.The plate is intact and just normal wear marks from the insertion and/or extraction procedure are visible.Therefore, as the dhr review has shown that the device was manufactured according to the specification, as we are not aware of any other complaint for this article- and lot combination and without knowing the allegation is the complaint unconfirmed for the plate.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.If additional information is made available, the investigation will be updated as applicable.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

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.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

It was further reported that patient underwent initial implant procedure on an unknown date in (b)(6) 2018.Further, upon removal of the devices, surgeon agreed that there was infection, tissue and swab were taken.Removal procedure was completed successfully.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10HOLE/230MM/LT-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: 7952774
• MDR Text Key: 123276680
• Report Number: 8030965-2018-57140
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455894
• UDI-Public: (01)07611819455894
• 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,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411S
• Device Lot Number: L694970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 11/13/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention