MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/4 HOLES/RIGHT; PLATE,FIXATION,BONE

Model Number	02.118.202
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device procode: hwc.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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 a patient had injury on or near (b)(6) 2018 and underwent implant procedure on (b)(6) 2018.Patient had two metal plates attached to her two lower leg bones.Post-operative, the plate was identified to be cracked on (b)(6) 2018, via x-ray.On (b)(6) 2018, patient underwent revision surgery due to a cracked variable angle-locking compression plate anterolateral distal tibia 4 holes/right.A crack had developed in one of the plates running from the side of one of those holes to the edge of the plate.The plate was removed and replaced with a larger one.The second surgery delayed the patient's recovery by four months.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant device: screws (part unknown, lot unknown, quantity 10).This report is for one (1) 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.Exact date of event is unknown.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the implant was not returned and instead will be do based on the supplied image the image was reviewed and the complaint condition for cracked for the implant was confirmed as the image there is crack along the second combi hole of the plate.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A device history review could not be performed as the lot number could not be determined from the supplied image.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During this investigation no product design or manufacturing issues were observed 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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/4 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: 8244912
• Report Number: 2939274-2019-55815
• Device Sequence Number: 16675938
• Product Code: HRS
• UDI-Device Identifier: 10886982038302
• UDI-Public: (01)10886982038302
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2018

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: 02.118.202
• Device Catalogue Number: 02.118.202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 02/11/2019; 02/15/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/05/2019; 02/12/2019; 02/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR