MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 20MM; SCREW, FIXATION, BONE

Model Number	02.210.120
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Additional device product code: hrs.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 during a procedure on (b)(6) 2018, a variable angle 2.4mm locking screw would not lock into a distal hole on the radial side of the volar two column distal radius plate.The screw was removed and replaced with another variable angle locking screw which then locked into the plate.This caused an approximate two (2) minute delay, however, the surgery was completed successfully with no patient consequence.No additional x-rays were taken.Concomitant part: volar two column distal radius plate (part: 02.111.631, lot number unknown, quantity one).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 20MM
• 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: 7359418
• Report Number: 2939274-2018-51141
• Device Sequence Number: 1470635
• Product Code: HWC
• UDI-Device Identifier: 10886982052971
• UDI-Public: (01)10886982052971(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 02.210.120
• Device Catalogue Number: 02.210.120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1