MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM; SCREW, FIXATION, BONE

Model Number	02.231.275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional patient identifier (b)(6); patient age, date of birth and weight are not available for reporting date of event: it is unknown when non-union began.Additional product codes jdp, hrs.Implant date is unknown.Complainant part is not expected to be returned.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, a patient underwent an open reduction internal fixation (orif) of the distal femur using synthes va condylar plate and screws.The outcome of the surgery was a nonunion.On (b)(6) 2018 the surgeon performed a revision orif of the distal femur to address the nonunion.The plates and screws were intact and successfully removed.A bone graft was inserted and a new synthes va condylar plate and screws were inserted in the patient.The revision was completed successfully with no harm to the patient.This is report 8 of 8 (b)(4).
Additional Manufacturer Narrative
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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7408033
• Report Number: 2939274-2018-51548
• Device Sequence Number: 1160959
• Product Code: HWC
• UDI-Device Identifier: 10886982062222
• UDI-Public: (01)10886982062222(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.231.275
• Device Catalogue Number: 02.231.275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention