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 Problems Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional pro codes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.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 the patient underwent revision surgery due to a broken variable angle locking compression plate (va lcp) curved condylar plate on (b)(6) 2019.Originally, the patient was implanted with the va lcp curved condylar plate and locking screws for a right distal femur fracture in (b)(6) 2019.On an unknown date after the surgery, the patient felt a pop while walking and experienced pain and difficulty in walking.The patient then went to the hospital and discovered that the plate broke, but the screws were intact.The surgeon was going to remove the broken plate and replace with another plate but when the affected area was opened, an infection was noted.The surgeon placed antibiotic cement beads around the fracture and performed a spanning exfix to hold the fracture at length for stability until the infection resides.It is unknown if there was a surgical delay.All the implants were successfully explanted.Procedure and patient outcome are unknown.This complaint involves nine (9) devices.This report is for one (1) 4.5 mm va-lcp curved condylar plate/12 hole/266mm/right.This is report is 1 of 9 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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) ¿ (b)(4) intake email with pictures from sales consultant 20sep2019¿.The image(s) was reviewed, and the complaint condition is confirmed as the device is broken which is seen in the picture so the complaint is confirmed.Since the device was not returned, dimensional, material and drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design 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.

• 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: 9173276
• MDR Text Key: 166792267
• Report Number: 2939274-2019-61359
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention