MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	02.211.016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hrs.Reporter is synthes sales consultant.(b)(4).A product investigation was conducted.Visual inspection: 2.7mm va lckng screw slf-tpng with t8 stardrive recess 16mm was returned and received at us cq.Upon visual inspection at us cq, the threads were observed to be stripped under 10x magnification.Functional test: functional testing of the device performed at cq by screwing in the screw into the lateral distal fibula plate that returned along with the device.It is found that the screw holes dva1 and dva3 of the plate are not locking the screws and just keep screws spinning in the locking holes.Thus, the reported complaint condition is confirmed.Dimensional inspection: dimensional inspection of the screw was performed at cq.The diameter of the screw was intended to be ranging from 2.6mm to 2.7mm and it was measured to be 2.67mm and the length of the screw was intended to be ranging from 16.0mm and 16.7mm and it was measured to be 16.40mm which is within specification as per the drawing 2.7mm locking screw self tapping with stardrive recess: 202_206 rev.C investigation conclusion: the complaint was confirmed for the 2.7mm va lckng screw self-tapng with t8 stardrive recess 16mm as the screw is not locking in 2 screw holes dva1 and dva3 of the plate.There was no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that condition was due to rough handling or excessive external forces applied on the device during the usage of the device.Based on the investigation findings, it is determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 an unknown date, while the surgeon was using a variable angle lateral distal fibula plate and placed a variable angle threaded drill guide from the universal small fragment (usf) into the plate and drilled with a 2.0 drill bit for 2.7 variable angle locking screws, two (2) of the holes would not lock and the screws would just spin in the locking hole during open reduction and internal fixation (orif) of the ankle.Total 5 screws were used and would not lock.There was a surgical delay of thirty (30) minutes.Procedure was successfully completed by using a different 2.7/3.5 variable angle lateral distal fibula plate and different screws.No patient consequence.Concomitant device reported: unk - guides/sleeves/aiming: guide (part# unknown, lot# unknown, quantity# 1), unk - drill bits: trauma (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 2.7mm va locking screw 16mm.This is report 4 of 6 for complaint.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• 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: 9072330
• Report Number: 2939274-2019-60604
• Device Sequence Number: 11258649
• Product Code: HWC
• UDI-Device Identifier: 10886982053596
• UDI-Public: (01)10886982053596
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.211.016
• Device Catalogue Number: 02.211.016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention