MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/20HOLE/405MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.420S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of implant reported as (b)(6) 2017.Returned to manufacturer concomitant devices therapy date reported as (b)(6) 2017.Subject device has been received and is currently in the evaluation process.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 (b)(4) reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) for a comminuted distal femur in (b)(6) 2017.Reduction was satisfactory.On unknown date it was revealed the 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate-20 hole-405mm right was broken.The plate spanned the length of the femur and had extremely bad comminuted fractures of both femur and tibia.Patient was returned to surgery on (b)(6) 2017 where all hardware was removed.It is not known if additional hardware was implanted.Concomitant devices reported: 5.0mm va locking screw self tapping stardrive 60mm (02.231.260, lot 9912656, quantity 1), 5.0mm va locking screw self tapping stardrive 70mm (02.231.270, lot 9856407, quantity 1), 5.0mm va locking screw self tapping stardrive 46mm(02.231.246, lot 9547059, quantity 1), 5.0mm va locking screw self tapping stardrive 38mm(02.231.238, lot 9714888, quantity 1), 5.0mm va locking screw self tapping stardrive 40mm(02.231.240, lot 9763902, quantity 1), 5.0mm va locking screw self tapping stardrive 95mm(02.231.295, lot 9172450, quantity 2), 5.0mm va locking screw self tapping stardrive 90mm (02.231.290, lot 9263539, quantity 1).This report is for one (1) 4.5mm va lcp curved condylar plate this is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed for part number: 02.124.420s, synthes lot number: 9125239: release to warehouse date: 10.Sep.2014, expiry date: 01.Sep.2024, manufacturing side: (b)(4): no non-conformance reports (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.A manufacturing investigation was performed.The received part was forwarded to the responsible manufacturing site for investigation, here is the statement: upon visual inspection the part is broken at level of the va.7 hole, this thus confirming the complaint description.A device history record (dhr) review was performed for the affected lot, 4 parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in september 2014.No ncrs were marked in the dhr during production.The lot was manufactured starting from raw material lot 17422.The certificate of the raw material has been reviewed.In the relative certificate, it is reported that the material is conforming.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Conclusion: considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned items, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Disposition: the manufacturing investigation is disposed as confirmed due to evidence that the part is broken, but it's considered not valid for (b)(4) because there is no evidence of issues manufacturing related.No manufacturing related issue was identified.Unfortunately we are not able to determine the exact reason for this occurrence.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/20HOLE/405MM/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7073543
• MDR Text Key: 93416170
• Report Number: 8030965-2017-50210
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455986
• UDI-Public: (01)07611819455986(17)240901(10)9125239
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.420S
• Device Lot Number: 9125239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention