MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMOOTH WIRE/1.8MM DIAMETER 400MM LONG; APPLIANCE,FIXATION,NAIL

Model Number	03.311.032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown date in 2019.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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a maxframe adjustment.The surgeon wanted to add a foot support kit and change a wire.It was noted that the skin incision was not relaxed enough initially along with initial swelling may have caused redness due to tenting of skin.That is why the smooth wire was removed and placed it with new reduction wire.Wire was intact.The procedure was successfully completed with no surgical delay.Patient status is unknown.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 not returned, the investigation could not be completed; no conclusion could be drawn at the time of filing 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: SMOOTH WIRE/1.8MM DIAMETER 400MM LONG
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8793479
• Report Number: 2939274-2019-59200
• Device Sequence Number: 2043803
• Product Code: KTT
• UDI-Device Identifier: 10886982077974
• UDI-Public: (01)10886982077974
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 03.311.032
• Device Catalogue Number: 03.311.032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 111