MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 28MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.019.028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown event date between (b)(6) 2020.Complainant part is not expected to be returned for manufacturer review/ investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 that on (b)(6) 2020, a revision surgery occurred due to fracture displacement and impaired healing.No implant malfunctions occurred.All hardware was removed.It is unknown what implants the patient was revised to.The original surgery and implantation with the multiloc humeral nailing system occurred on (b)(6) 2020.The patient outcome is unknown.This is report 5 of 7 for (b)(4).

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 28MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10600460
• Report Number: 2939274-2020-04379
• Device Sequence Number: 16907829
• Product Code: HSB
• UDI-Device Identifier: 10886982089700
• UDI-Public: (01)10886982089700
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 04.019.028
• Device Catalogue Number: 04.019.028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM TI LOCKING SCR 30MM; 3.5MM TI LOCKING SCR 36MM; 4.0MM TI LOCKING SCREW 20MM; 4.0MM TI LOCKING SCREW 22MM; 4.5MM TI MULTILOC SCREW LENGTH 34MM; 7MM TI MULTILOC HUMERAL NAIL 225MM-S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR