MAUDE Adverse Event Report: ARTHREX, INC. FRAC PLT SCRW LOC. CANC. 4.0X34MM TI; PLATE, FIXATION, BONE

Model Number	FRAC PLT SCRW LOC. CANC. 4.0X34MM TI
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	07/19/2018
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 tip was left in the patient and the remaining portion of the device was reported to have been discarded at the facility.Therefore, the device was not returned for evaluation.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 during a proximal suture plate removal procedure, as the surgeon went to remove the screws, the screw tips on each screw became detached and remained in the far cortex of the patient¿s humerus.The surgeon did not attempt to retrieve the tips and no extra surgery is scheduled to remove the tips either.The patient condition was stable.Hardware removed: ar-14003, ar-14128nl, ar-14124nl, ar-14242, ar-14240, ar-14236, ar-14234, ar-14126.Additional information provided 7/27/2018: the removal surgery date was (b)(6) 2018.The original surgery (first implanted date) is (b)(6) 2017.The screws and plate were removed as the one was healed.The implantation of the plate and screws was temporary.All explanted screws were discarded.

• Brand Name: FRAC PLT SCRW LOC. CANC. 4.0X34MM TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7738765
• Report Number: 1220246-2018-00587
• Device Sequence Number: 16404036
• Product Code: HRS
• UDI-Device Identifier: 00888867017368
• UDI-Public: 00888867017368
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K041965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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: FRAC PLT SCRW LOC. CANC. 4.0X34MM TI
• Device Catalogue Number: AR-14234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/01/2018
• 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