MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.416
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes hwc, hrs.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 or Problem Description
It was reported that the patient underwent an open reduction internal fixation (orif) of periprosthetic femur fracture on (b)(6) 2019, the variable angle (va) curved condylar plate broke after being implanted to the patient for 3 months.A patient came back to have the plate removed that the patients leg wasn`t straight and can`t walk.A new procedure performed to fix the femur which displaced after the plate broke.It is unknown if there was a surgical delay.Procedure successfully completed.Patient outcome is unknown.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity 1).This report is for one (1) 4.5mm va-lcp curved condylar plate/16 hole/336mm/right.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.Device history lot, part: 02.124.416, lot: l912189, manufacturing site: mezzovico, release to warehouse date: 05.June 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material was confirmed to be correct per the specification with no non-conformance noted.H3, h6: investigation summary updated event description: it was reported that the patient underwent an open reduction internal fixation (orif) of periprosthetic femur fracture on march 26, 2019, the variable angle (va) curved condylar plate broke after being implanted to the patient for 3 months.A patient came back to have the plate removed that the patients leg wasn`t straight and can`t walk.A new procedure performed to fix the femur which displaced after the plate broke.It is unknown if there was a surgical delay.Procedure successfully completed.Patient outcome is unknown.The implant(s) was not returned and instead will be do based on the supplied image(s) from the attachments (2 image(s) from the 2 attachment(s) located in notes & attachments section of the product complaint) the image(s) was reviewed and the complaint condition could was confirmed, as it shows the plate broke between ninth and tenth combi hole (proximal to distal end).As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A device history review, was performed for the returned implant¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.The raw material was confirmed to be correct per the specification with no non-conformance noted.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 images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
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.Complainant part is not expected to be returned for manufacturer review/investigation.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.Date of event: it is unknown when the plate broke.Concomitant device reported: 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
5/13/2019: updated event description: it was reported that on (b)(6) 2019, the patient underwent removal of variable angle (va) curved condylar plate that broke after being implanted in the patient 3 months prior.The patient's leg was not straight and patient cannot walk.Originally, the patient underwent open reduction internal fixation (orif) of periprosthetic femur fracture on an unknown date.The patient received a femoral nail to fix the femur which displaced after the plate broke.It is unknown if there was a surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity 1).This complaint involves one (1) device.
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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• 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: 8531491
• Report Number: 2939274-2019-57570
• Device Sequence Number: 1840375
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416
• Device Lot Number: L912189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 05/09/2019; 05/13/2019; 05/20/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/09/2019; 05/09/2019; 05/15/2019; 05/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR