MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	11/15/2018
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 was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
Information from the surgical outcome system was received that there was an incident with an arthrex product during a shoulder arthroscopy.It was reported that it came to complications and the patient had an infection after surgery.A revision surgery is required to remove the implant.The primary surgery took place in (b)(6) 2018 with an arthrex mid shaft / central third plate for clavicle fracture.At the moment we do not have further information.The surgeon was contacted to receive all the necessary information to evaluate this case.On 08 jan 2019 additional information obtained: the primary surgery took place on (b)(6) 2018.A osteosynthesis of a fractured collar bone was performed with device ar-2652cl.As there was a late infection of the implanted plate a revision surgery took place on (b)(6) 2018 where the plate was removed from the patient.On 09 jan 2019 additional information obtained: the surgeon has confirmed that this was reported through the surgical outcome system and was being reported as a non-product related issue.The surgeon has stated the following to the sales rep: the infection is not related to the product.The plate and screws are non-sterile devices and were sterilized at the hospital.The arthrex product was not the fault of the infection.No further information will be received.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8286727
• Report Number: 1220246-2019-00866
• Device Sequence Number: 19448647
• Product Code: HRS
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other