MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM-STERILE; APPLIANCE, FIXATION, NAIL

Model Number	280.295S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id reported as (b)(6).Date of event is unknown.Additional product code: jdq.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record review has been requested.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 underwent removal of one (1) dynamic hip screw (dhs) / dynamic condylar screw (dcs) one-step lag screw, one (1) 130 degree dhs plate-standard barrel 2-holes/46 mm, and one (1) unknown trauma cortex screw on (b)(6) 2018 due to return of benign neoplasm (tumor) and suspected infection.The construct was initially implanted on (b)(6) 2018.The removal procedure included use of a cement spacer.The procedure was successfully completed with patient outcome reported as ok.This report is for a dhs®/dcs® one-step lag screw 12.7mm thread/95mm-sterile.This is report 2 of 3 for (b)(4).

• Brand Name: DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM-STERILE
• 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: 7501985
• Report Number: 2939274-2018-52112
• Device Sequence Number: 167725
• Product Code: KTT
• UDI-Device Identifier: 10886982175182
• UDI-Public: (01)10886982175182
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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 Expiration Date: 02/28/2026
• Device Model Number: 280.295S
• Device Catalogue Number: 280.295S
• Device Lot Number: H302655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/10/2018
• 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
• Patient Age: 18 YR
• Patient Weight: 62