MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM; SCREW,FIXATION,BONE

Model Number	02.211.030
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was not provided for reporting.Product code: additional device code: hrs.Explanted date: device remained implanted.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, the patient underwent an unknown procedure.During the procedure the variable angle (va) locking screw was not locked into the plate.The locking screw was implanted.There was no surgical delay reported.The patient and surgery outcome were reported as unknown.Concomitant device reported: 2.7mm/3.5mm variable angle locking compression plate (part # 02.117.901, lot # unknown, quantity # 1).This report is for one (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 30mm.This is report 1 of 10 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM
• 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: 7675111
• Report Number: 2939274-2018-52787
• Device Sequence Number: 1528168
• Product Code: HWC
• UDI-Device Identifier: 10886982053664
• UDI-Public: (01)10886982053664
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: 02.211.030
• Device Catalogue Number: 02.211.030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1
• Patient Age: 62 YR