MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Model Number	202.212
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: hrs, ktt.Device malfunctioned intra-operatively and was not implanted / 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 patient underwent an open reduction internal fixation (orif) of the ankle on (b)(6) 2018.During the procedure, the surgeon attempted to insert a 2.7mm locking screw into the distal fibular plate, but the locking screw would not grip the threads of the plate.The screw was easily removed and replaced with another 2.7mm locking screw.Surgery was completed with a delay of approximately 5 minutes.No patient consequence was reported.Concomitant devices reported: distal fibular plate (part number unknown, lot number unknown, quantity 1) this report is for one (1) 2.7mm locking screw this is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• 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: 7611764
• Report Number: 2939274-2018-52534
• Device Sequence Number: 2195524
• Product Code: HWC
• UDI-Device Identifier: 10886982143969
• UDI-Public: (01)10886982143969
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 05/22/2018

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: 202.212
• Device Catalogue Number: 202.212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR