MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW,FIXATION,BONE

Model Number	02.211.014
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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) 2018, patient underwent procedure for an open reduction internal fixation (orif) olecranon fracture.During the procedure, a locking screw would not lock into the left olecranon plate.The surgeon tried to insert the screw in on power then switched to manual, but was still unsuccessful.The interface between the plate and screw did not lock into the plate.There was a two-minute surgical delay to obtain another of the same screw which was inserted in a different hole in the plate.The plate and ten (10) screws were implanted.The surgery was successfully completed.The patient outcome was as expected.Concomitant devices reported: power screwdriver (part# unknown, lot# unknown, quantity 1).Screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 14mm.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
• 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: 7385137
• Report Number: 2939274-2018-51352
• Device Sequence Number: 11036003
• Product Code: HWC
• UDI-Device Identifier: 10886982053589
• UDI-Public: (01)10886982053589(10)(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/02/2018

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: 02.211.014
• Device Catalogue Number: 02.211.014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR