MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW, FIXATION, BONE

Model Number	02.210.114
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).Without a lot number the device history records review could not be completed.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2.4mm va locking screw 14mm.This is report 3 of 6 for complaint.
Event or Problem Description
Update: this report is for one (1) 2.4mm va lckng screw slf-tpng with t8 stardrive recess 14mm.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary background updated event 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.There was a surgical delay of thirty (30) minutes.Procedure was successfully completed by using a different 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 complaint involves six (6) devices.Investigation flow (damage) visual inspection: 2.4mm va lckng screw stardrive 14mm was returned and received at us cq.Upon visual inspection at us cq, no physical damage was observed on the surface of the device.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 dva2, dva4, dva5, and dva6 of the plate are locking the screws in right position.But the screws are not locking in the holes dva1 and dva3 due to the stripped internal threads of the holes.Thus, the reported complaint condition is not confirmed.Document/specification review: 2.4mm variable angle locking screw self ¿ tapping, stardrive recess: 02_210_106 rev j ¿ current revision.Sb-threads-m&q: se_105512_ac rev.3.Investigation conclusion: the complaint was not confirmed for the 2.4mm va lckng screw stardrive 14mm as the screw is locking in 4 screw holes dva2, dva4, dva5, and dva6 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.

• Brand Name: 2.4MM 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: 9072293
• Report Number: 2939274-2019-60602
• Device Sequence Number: 16581748
• Product Code: HWC
• UDI-Device Identifier: 10886982052919
• UDI-Public: (01)10886982052919
• 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,Followup
• 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: 02.210.114
• Device Catalogue Number: 02.210.114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Outcome Attributed to Adverse Event: Required Intervention