MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/RIGHT; PLATE,FIXATION,BONE

Model Number	02.118.204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 an unknown date, one (1) variable angle locking compression plate anterolateral distal tibia plate, one (1) variable angle locking compression plate distal tibia t-plate, and one (1) locking compression plate broke due to patient falling.Patient had nonunion.As a result, on an unknown date, the hardware of the ankle were removed and replaced with a synthes max frame.It was unknown it there was any surgical delay.Patient outcome is unknown.Concomitant device: screw (part unknown, lot unknown, quantity unknown).This report is for one (1) tibia plate.This is report 1 of 3 for (b)(4).
Event or Problem Description
Additionally, it was reported the original implant date is unknown.It is unclear what caused the patient to fall or if it was related to the non-union.A revision procedure was performed on (b)(6) 2018; there was no surgical delay.There were no fragments generated from the broke device.No additional medical intervention or x-rays related to the complained event were required.
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 one (1) variable angle locking compression plate anterolateral distal tibia plate broke due to fall.The fracture caused non-union.The patient was initially implanted with a variable angle locking compression plate anterolateral distal tibia plate, variable angle locking compression plate distal tibia t-plate and locking compression plate on an unknown date.As a result, the hardware was removed and was replaced with a synthes max frame.It was unknown if there was any surgical delay.Patient outcome is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # unknown).Variable angle locking compression plate distal tibia t-plate (part # 02.118.307, lot # unknown, quantity # 1).Locking compression plate (part # 249.683, lot # unknown, quantity # 1).This report is for one (1) 2.7/3.5mm va-lcp anterolateral distal tibia plate.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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/RIGHT
• 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: 8025744
• Report Number: 2939274-2018-54715
• Device Sequence Number: 1381801
• Product Code: HRS
• UDI-Device Identifier: 10886982038340
• UDI-Public: (01)10886982038340
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2018

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: 02.118.204
• Device Catalogue Number: 02.118.204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 11/18/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention