MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 24MM; NAIL, FIXATION, BONE

Model Number	212.108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age/date of birth and weight are unknown.Unknown date in 2017.Additional product code: ktt.Device was scheduled to be explanted on (b)(6), 2017.It is unknow if that procedure occurred as planned.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Original surgery to treat a left proximal humerus fracture was performed on (b)(4) 2017.The patient was implanted with sixteen (16) synthes devices which include twelve (12) locking screws, three (3) cortex screws and one (1) plate.The patient returned on an unknown date for post-operative x-rays.The x-rays revealed non-union as the fracture did not heal as expected.It was also reported that the patient had fallen multiple times post-operatively and was non-complaint with post-operative care.To address the non-union, surgeon will be performing a revision for hardware removal on (b)(6), 2017.It has been decided that all of the 16 implanted devices will be removed.Patient will be revised to a different treatment plan and no new devices will be implanted; it is unknow if that procedure occurred as planned.There was no reported product problem and per the x-rays, the devices appeared to be intact.This is report 3 of 16 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 24MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7070667
• Report Number: 2939274-2017-50072
• Device Sequence Number: 1119699
• Product Code: JDS
• UDI-Device Identifier: 10886982151827
• UDI-Public: (01)10886982151827(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 212.108
• Device Catalogue Number: 212.108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention