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	Pain (1994); Discomfort (2330)
Date of Event	10/24/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was previously reported that a patient had a revision procedure on (b)(6) 2019 due to a broken clavicle plate (case (b)(4)).On (b)(6) 2019 the patient started experiencing pain and discomfort, and recognized that their clavicle had moved and their skin was tenting.The patient had a follow-up visit with their surgeon on (b)(6) 2019, and the x-rays taken during the follow-up reveled the implanted hardware had broken.The second revision procedure was performed on (b)(6) 2019.Copies of x-rays were provided and have been attached to the complaint record.The arthrex part and lot numbers that were explanted and implanted during the (b)(6) 2019 revision procedure are currently unknown.Additional information received on 12/12/2019: the rep provided the part numbers of the arthrex product used and implanted during the (b)(6) 2019 revision procedure.The rep reported all implanted arthex product was explanted during the second revision procedure that took place on (b)(6) 2019.The part numbers of devices implanted during the (b)(6) 2019 procedure is still unknown at this time.The following arthrex products were used during the revision 07/05/2019 procedure; ar-2653cl // lot: 5261824 // qty.: 1, ar-8835-12 // lot: 10227335 // qty.: 1, ar-8835-12 // lot: 10239798 // qty.: 1, ar-8835-14 // lot: 10285356 // qty.: 2, ar-8835l-14 // lot: 10293298 // qty.: 1, ar-8835l-14 // lot: 10298303 // qty.: 3, ar-8835l-16 // lot: 10223166 // qty.: 2.Additional information received on 12/13/2019: the sales rep reported no explanted devices are available to return, and the same arthrex sales representative was present for all procedures.The rep reported the surgeon used accumed plating system in the (b)(6) 2019 procedure.Superior and anterior accumed plates were used to complete the procedure.

• 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: 9519555
• Report Number: 1220246-2019-01537
• Device Sequence Number: 11574247
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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-2653CL
• Device Lot Number: 5261824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/26/2019
• 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