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

Model Number	02.211.012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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) 2020, nonunion occurred and 6-hole va-lcp medial distal plate with six 2.7mm va locking screws, three 3.5 cortical screws, and one 3.5 locking screw were all removed.The screw head may have already been broke prior to the removal case.There was no surgical delay reported.The patient was stable after the procedure.The procedure was successfully completed.This complaint involves twelve (12) devices.This report is for (1) 2.7mm va locking screw slf-tpng with t8 stardrive recess 12mm.This is report 8 of 10 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10818364
• Report Number: 2939274-2020-05089
• Device Sequence Number: 19114393
• Product Code: HRS
• UDI-Device Identifier: 10886982053565
• UDI-Public: (01)10886982053565
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.211.012
• Device Catalogue Number: 02.211.012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LWPROF CORTSCR ø3.5 SELF-TAP L16 SST; UNK - PLATES; VA LOCKSCR Ø3.5 SELF-TAP L58 SST
• Outcome Attributed to Adverse Event: Required Intervention