MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hrs, hwc.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review is pending completion.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 or Problem Description
It was reported that on (b)(6) 2018, patient underwent secondary operation.During the procedure, while taking the antibiotic bead out of the patient, a 4.5 mm va-lcp condylar plate set with 18 holes on the left side was found to have a small breakage.Additional operative time, length unknown, was needed in the orthopedic procedure.Patient outcome is unknown.Concomitant devices reported: 4.5 cortex screws (part# unknown, lot# unknown, qty: unknown) 5.0 va locking screws (part# unknown, lot# unknown, qty: unknown) this report is for one (1) 4.5mm va-lcp curved condylar plate/18 hole/370mm/left.This is report 1 of 1 for (b)(4).
Additional 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.Date returned to manufacturer 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.
Additional 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 or Problem Description
It was reported that patient had a cracked 4.5 mm variable angle -locking compression plate (va-lcp) condylar plate.Patient was implanted on an unknown date with an unknown nail.Patient presented with an infection and was revised with a va-lcp condylar plate and antibiotic beads on an unknown date.Patient was scheduled for planned revision on (b)(6) 2018 to remove the antibiotic beads and to have a bone graft.While removing the antibiotic beads, the plate was found to have had a crack in it.The plate was explanted and a unknown nail was implanted.Concomitant devices: 4.5 cortex screws (part #: unknown, lot #: unknown, qty: unknown) 5.0 va locking screws (part #: unknown, lot #: unknown, qty: unknown).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT
• Common Device Name: 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: 7473108
• Report Number: 2939274-2018-51953
• Device Sequence Number: 1607875
• Product Code: JDP
• UDI-Device Identifier: 10886982042996
• UDI-Public: (01)10886982042996
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: 02.124.419
• Device Catalogue Number: 02.124.419
• Device Lot Number: L437415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 06/05/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/30/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR