MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM; APPLIANCE,FIXATION,NAIL

Model Number	212.104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Provided on facility report (b)(4).Additional product code: jds.It is not known if this was one of eleven screws explanted.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.(b)(4).
Event or Problem Description
Customer quality unit received a user facility report forwarded from (b)(6) hospital; this report is against user facility medwatch report # (b)(4).Only additional and/or corrected information will be contained in this report.It was reported patient underwent a procedure in which the 2.7mm/3.5mm locking compression plate (lcp) posterolateral distal fibula plate and thirteen (13) screws for a clavicle fracture on (b)(6) 2017.On unknown date patient developed an infection at the implant site.Patient was returned to surgery on (b)(6) 2018 where surgeon removed eleven (11) of the screws and the plate.It is unknown why two (2) of the screws remain implanted.Surgery was completed.Patient status reported as okay.This report is for one (1) 3.5mm locking screw 16mm.This is report 10 of 10 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7434765
• Report Number: 2939274-2018-51745
• Device Sequence Number: 194458
• Product Code: KTT
• UDI-Device Identifier: 10886982151780
• UDI-Public: (01)10886982151780
• Combination Product (Y/N): N
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 212.104
• Device Catalogue Number: 212.104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/16/2018
• 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