MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 20MM; SCREW, FIXATION, BONE

Model Number	02.210.120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hrs.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2020, the patient underwent removal of hardware due to pain.Patient was originally implanted with one (1) variable locking compression plate, two (2) cortex screws, and five (5) locking screws on unknown date.The surgeon removed the plate and screws successfully and nothing was broken.The patient outcome is unknown.Concomitant devices reported: 2.4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/2h shaft/right (part # 02.111.720, lot # unknown, quantity 1); 2.4mm va locking screw stardrive 20mm (part # 02.210.120, lot # unknown, quantity 4); 2.7mm cortex screw slf-tpng with t8 stardrive recess 16mm (part # 202.876; lot # unknown, quantity 2).This report is for one (1) 2.4mm va locking screw stardrive 20mm.This is report 7 of 8 for (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 20MM
• 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: 10667115
• Report Number: 2939274-2020-04628
• Device Sequence Number: 14340682
• Product Code: HWC
• UDI-Device Identifier: 10886982052971
• UDI-Public: (01)10886982052971
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2020

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: 02.210.120
• Device Catalogue Number: 02.210.120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention