MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.412

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional pro-codes: hrs, hwc.(b)(4).A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; 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

It was reported that on (b)(6) 2019, patient underwent a revision surgery of the right distal femur due to a broken variable angle locking compression plate (va-lcp) curved condylar plate and non-union.The patient originally had an open reduction and internal fixation (orif) of the right distal femur on december 28, 2018.At the time of the first surgery the patient was implanted with a 4.5 va-lcp curved condylar plate 12 hole right plate and three (3) 4.5 cortex screws and ten (10) 5.0 locking screws.During the revision, the surgeon removed the broken plate, the screws and replaced with a retrograde nail to stabilize the fracture.All hardware were removed successfully.It was unknown if there was a surgical delay.Procedure was completed.There was no patient consequence.Concomitant devices reported: 4.5 cortex screw self-tapping 70mm (part #:214.870, lot#: unknown, quantity #:1).4.5 cortex screw self-tapping 66mm (part #:214.866, lot#: unknown, quantity #:1).4.5mm cortex screw self-tapping 36mm (part #:214.836, lot#: unknown, quantity #:1).5.0mm va locking screw/strdrv/self tapping 70mm (part #: 02.231.270, lot#: 2l35743, quantity #:1).5.0 va locking screw/strdrv/self tapping 80mm (part #:02.231.280, lot#: 2l26487, quantity #:1).5.0 va locking screw/strdrv/self tapping 80mm (part #:02.231.280, lot#: 1l61745, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 36mm (part #:02.231.236, lot#: 2l26412, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 36mm (part #:02.231.236, lot#: 2l26417, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 38mm (part #:02.231.238, lot#: l999189, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 38mm (part #:02.231.238, lot#: 2l02877, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 46mm (part #:02.231.246, lot#: 1l05410, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 50mm (part #:02.231.250, lot#: 2l13290, quantity #:1).5.0 mm va locking screw/strdrv/self tapping 65mm (part #:02.231.265, lot#: 2l35719, quantity #:1).This complaint involves one (1) device.This report is 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.A review of the device history record device history lot , part: 02.124.412, lot: l980833, manufacturing site: mezzovico, release to warehouse date: 24.July.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified investigation summary complaint description: it was reported that on (b)(6) 2019, patient underwent a revision surgery of the right distal femur due to a broken variable angle locking compression plate (va-lcp) curved condylar plate and non-union.The patient originally had an open reduction and internal fixation (orif) of the right distal femur on (b)(6) 2018.At the time of the first surgery the patient was implanted with a 4.5 va-lcp curved condylar plate 12-hole right plate and three (3) 4.5 cortex screws and ten (10) 5.0 locking screws.During the revision, the surgeon removed the broken plate, the screws and replaced with a retrograde nail to stabilize the fracture.All hardware was removed successfully.It was unknown if there was a surgical delay.Procedure was completed.There was no patient consequence.Concomitant devices reported: 4.5 cortex screw self-tapping 70mm (part #:214.870, lot#: unknown, quantity #:1), 4.5 cortex screw self-tapping 66mm (part #:214.866, lot#: unknown, quantity #:1), 4.5mm cortex screw self-tapping 36mm (part #:214.836, lot#: unknown, quantity #:1), 5.0mm va locking screw/strdrv/self tapping 70mm (part #: 02.231.270, lot#: unknown, quantity #:1), 5.0 va locking screw screw/strdrv/self tapping 80mm (part #:02.231.280, lot#: unknown, quantity #:2), , 5.0 mm va locking screw/strdrv/self tapping 36mm (part #:02.231.236, lot#: unknown, quantity #:2), 5.0 mm va locking screw/strdrv/self tapping 38mm (part #:02.231.238, lot#: unknown, quantity #:2), 5.0 mm va locking screw/strdrv/self tapping 46mm (part #:02.231.246, lot#: unknown, quantity #:1), 5.0 mm va locking screw/strdrv/self tapping 50mm (part #:02.231.250, lot#: unknown, quantity #:1), 5.0 mm va locking screw/strdrv/self tapping 65mm (part #:02.231.265, lot#: unknown, quantity #:1).Investigation flow: damage.Visual inspection: the 4.5mm va-lcp curved condylar plate/12 hole/266mm/right (part # 02.124.412, lot # l980833) was returned to us cq.A visual inspection was performed.The lcp curved condylar plate was broke into two pieces.Point of fracture is close to the center of the plate.Rest of the device shows scratches and corrosion at a locking compression hole which is consistent implantation and has no impact on the functionality of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: ¿ va lcp curved condylar plate 6-22 holes / left and right: se_366691, rev.H.Investigation conclusion: the device received is broken, confirming the allegation.The complaint condition is confirmed as the 4.5mm va-lcp curved condylar plate/12 hole/266mm/right (p/n 02.124.412, l/n l980833) is broken into two pieces close to the center.There is no indication that a design or manufacturing issue has caused the breakage of the device and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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/12 HOLE/266MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8746174
• MDR Text Key: 149643385
• Report Number: 2939274-2019-58921
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.412
• Device Catalogue Number: 02.124.412
• Device Lot Number: L980833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR