MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 22MM; SCREW, FIXATION, BONE

Model Number	02.210.122
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth and age is unknown; age reported as early 20¿s.Patient weight is unknown; reported as slender.Additional product code: hrs.Device has not been reported as explanted.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 distal radius fracture procedure that the patient underwent on (b)(6) 2018, an unknown variable angle (va) locking screw was stripped when it was put in the va locking compression plate (lcp) two-column volar distal radius plate.There were no visible fragments generated from the stripped screw.The surgeon took quite some time in deciding to leave the screw inside, which caused an approximate thirty (30) minute surgical delay.The procedure was successfully completed, but it is unknown what the patient outcome was.Concomitant device reported: va lcp two-column volar distal radius plate 2.4mm (part 02.111.631s, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 22MM
• 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: 7704484
• Report Number: 2939274-2018-52984
• Device Sequence Number: 789883
• Product Code: HWC
• UDI-Device Identifier: 10886982052995
• UDI-Public: (01)10886982052995
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 02.210.122
• Device Catalogue Number: 02.210.122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/19/2018
• Patient Sequence Number: 1