MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when device broke.Additional procodes: hrs, hwc.Lot number is unknown.Date of implantation is unknown date one year prior to explantation.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unavailable.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 or Problem Description
It was reported that on (b)(6) 2018, the patient underwent removal of a broken variable angle -locking compression (va-lcp) curved condylar plate.It was reported that the femur plate was in a patient for a year and the patient did not heal.During the removal, patient underwent bone grafting and was revised to a new plate.It is unknown if there was a surgical delay.Patient outcome is unknown.Concomitant device reported: trauma screw (part: unknown, lot: unknown, quantity: unknown).This report is for a 4.5mm va-lcp curved condylar plate/10 hole/230mm/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.The implant was not returned and instead investigation will be done based on the supplied x-rays.Both images were reviewed and the complaint condition of broken postop was confirmed as the plate has broken into two pieces, the break appears to be traverse and towards the proximal side.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A dhr review for the manufacturing records and the material records could not be performed as the lot number is unknown.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Patient underwent removal of hardware on (b)(6) 2018.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/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: 7682003
• Report Number: 2939274-2018-52847
• Device Sequence Number: 19044519
• Product Code: JDP
• UDI-Device Identifier: 10886982042835
• UDI-Public: (01)10886982042835
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2018

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: 02.124.411
• Device Catalogue Number: 02.124.411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/09/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention