MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA-LCP CONDYLAR PLATE 4.5/5.0 LE 18HO L3; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.419S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 synthes reports an event in (b)(6) as follows: it was reported on january 14th 2020 that a vaco plate and screws were used during a distal femoral orif at the (b)(6) hospital.On (b)(6) 2020, the patient was brought back to theatre as the distal screws had backed out.All devices were removed.At time of original surgery the surgeon is confident that all screws were torqued off using the correct screwdriver from the set.The procedure was successfully completed.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity#: 1).This complaint involves eight (8) devices.This is 1 of 8 for report (b)(4).

Event Description

It was reported that the patient was revised to another variable angle-locking compression (va-lcp) condylar 16 holes plate.Concomitant devices reported: screws (part # unknown, lot # unknown, quantity 7).

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.B5: added additional information and updated concomitant devices h6: reviewing attached picture, the complaint description can be confirmed as the distal screws had (six screws) backed out from the lcp plate.Product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: a device history record (dhr) review was conducted: part: 02.124.419s, lot: l967805, manufacturing site: mezzovico, release to warehouse date: 19.July 2018, expiry date: 01.July 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.B3: event year is reported as 2020, however exact date of postoperative migration is unknown.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: VA-LCP CONDYLAR PLATE 4.5/5.0 LE 18HO L3
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9705840
• MDR Text Key: 191321151
• Report Number: 8030965-2020-01079
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455979
• UDI-Public: (01)07611819455979
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.419S
• Device Lot Number: L967805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA (QTY 7)
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR