MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 10 HOLES 137MM; PLATE,FIXATION,BONE

Model Number	223.601
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown date in 2019.Additional product codes hwc, ktt.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 or Problem Description
It was reported that on (b)(6) 2019, the patient was riding his bike (noncompliant) and was hit by a car.The 3.5 tibial plate was badly bent after being hit by the car.The fracture lost alignment and reduction after the plate was bent.The plate and screws were removed, and a 4.5 lcp plate was implanted.There was no malfunction of the screws and they were easily removed.The patient is currently being evaluated by psychiatry as the initial injury is thought to be an attempted suicide.It is unknown if there was a surgical delay.Procedure outcome is unknown.Patient consequence is unknown.Concomitant devices reported: unk - screws: trauma (part# unknown, lot# unknown, quantity# 6).This report is for one (1) 3.5mm lcp plate 10 holes 137mm.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.Corrected data: awareness date of previous report (follow up 1) was reported as (b)(4) 2019 but should have been (b)(4) 2019.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
The patient was initially operated on (b)(6) 2019.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 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: 3.5MM LCP PLATE 10 HOLES 137MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8574496
• Report Number: 2939274-2019-57784
• Device Sequence Number: 2039227
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2019

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: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 06/05/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/31/2019; 06/05/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR