MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® GUIDE SHAFT; GUIDE, SURGICAL, INSTRUMENT

Model Number	338.21
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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, during an open reduction internal fixation for a patient with a right hip fracture, the dynamic hip, and condylar screw system ( dhs/ dcs) coupling screw and the dhs/ dcs guide shaft became bent and unusable upon insertion of the unknown dhs plate over the unknown lag screw.The surgeon tried a new coupling screw which subsequently became bent as well.The dhs/ dcs impactor was also damaged during this process.A portion of the gray tip chipped off during impaction.The surgeon had to use backup instrumentation from a second instrument tray to complete the procedure.There was a surgical delay of ten to fifteen ( 10- 15 ) minutes.The generated fragments were removed easily without additional intervention.There was no patient consequence reported.Concomitant devices reported: unknown dhs plate ( part# unknown, lot# unknown, quantity 1).Unknown lag screw ( part# unknown, lot# unknown, quantity 1).This report is for one (1) dhs®/dcs® guide shaft.This is report 1 of 2 for (b)(4).

• Brand Name: DHS®/DCS® GUIDE SHAFT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9727942
• Report Number: 2939274-2020-00901
• Device Sequence Number: 2100954
• Product Code: FZX
• UDI-Device Identifier: 10886982193247
• UDI-Public: (01)10886982193247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/27/2020

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: 338.21
• Device Catalogue Number: 338.21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1