MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; WASHER, BOLT NUT

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device remains in patient.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent an orif of left clavicle procedure on (b)(6) 2018 where an ar-2652cl, lot: unk was implanted.On (b)(6) 2018, an infection was noted on his skin during his post-op visit.The surgeon ordered antibiotics and had cultures done.The facility is currently awaiting the results, however, according to the surgeon, it has come back as (b)(6).A revision surgery has not been scheduled and it is unknown if one will be.The following devices were also implanted during the orif of left clavicle procedure: ar-8835-14 3.5 cortical screw 14mm x1, ar-8835-16 3.5 cortical screw 16mm x2, ar-8835l-16 3.5 locking screw 16mmx 3.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7718876
• Report Number: 1220246-2018-00568
• Device Sequence Number: 19058383
• Product Code: HTN
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2652CL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/25/2018
• 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: Other
• Patient Age: 20 YR