MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE, CENTRAL THIRDS, LEFT, STAINLESS STEEL; PLATE, FIXATION, BONE

Catalog Number	AR-2653CL
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was discarded therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause for the complainant's event was patient non-compliance with the post-op protocol.From the event it was stated that the patient was cooking and felt a sharp pain when he reached for a pot.This was about 6 weeks after the initial surgery.Per product directions for use (dfu-0192), post-operatively, until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the (b)(4) complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device reported to have been discarded.
Event or Problem Description
It was reported that the original procedure was on (b)(6) 2017.Patient was cooking on (b)(6) 2017 and felt a sharp pain when he reached for a pot.Thought the plate had broken.It was confirmed the following week.Plate was removed on (b)(6) 2017.Case: left clavicle patient: (b)(6) male.Approximately (b)(6).Additional information obtained 3/28/17: the following screws were also explanted when the surgeon explanted the clavicle fracture plate: ar-8835l-20 (qty 1), ar-8835l-18 (qty 3), ar-8840-10 (qty 2), ar-8835-08 (qty 1), ar-8835l-16 (qty 2), ar-8835-18 (qty 1), ar-8835-22 (qty 1).To complete the procedure the surgeon used another manufacturer's product.The plate breakage was mid-plate.

• Brand Name: CLAVICLE FRACTURE PLATE, CENTRAL THIRDS, LEFT, STAINLESS STEEL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6484939
• Report Number: 1220246-2017-00116
• Device Sequence Number: 1289009
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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 Catalogue Number: AR-2653CL
• Device Lot Number: 5261615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/12/2017
• 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: Other
• Patient Age: 55 YR
• Patient Weight: 84