MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM; APPLIANCE,FIXATION,NAIL

Model Number	280.900
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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) 2020, the patient underwent an intertrochanteric (it) hip fracture repair using dynamic hip screw system (dhs).During the procedure, the dynamic hip and condylar screw system (dhs/dcs) lag screw would not allow the plate barrel to slide as intended.The plate barrel was not the issue, as it was tried on other screw sizes and it slid effortlessly.The reason the barrel would not slide down the screw could not be identified, but the screw was the problem due possible damage.A 95mm lag screw was used instead of the intended 90mm.No fragments were generated.The procedure was successfully completed with a ten to fifteen (10-15) minutes surgical delay.There was no patient consequence.Concomitant device reported: plates: dhs/dcs (part number unknown, lot unknown, quantity 1).This report involves one (1) dhs/dcs lag screw 12.7mm thread/90mm.This is report 1 of 1 for (b)(4).

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM
• 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: 10091589
• Report Number: 2939274-2020-02517
• Device Sequence Number: 3881300
• Product Code: KTT
• UDI-Device Identifier: 10886982176318
• UDI-Public: (01)10886982176318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 280.900
• Device Catalogue Number: 280.9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: DHS/DCS