MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL 5TH METARSAL HOOK PLATE; PLATE, FIXATION, BONE

Model Number	UNIVERSAL 5TH METARSAL HOOK PLATE
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2019
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 reported by the patient that she had undergone a right foot metatarsal fracture procedure on (b)(6) 2019.The patient began having severe pain and on or about (b)(6) 2019 it was determined that the plate implant had broken.The patient underwent a revision surgery by the same surgeon, at the same facility, on (b)(6) 2019.During the revision procedure, the plate and corresponding screws were explanted.At the time of the patient's initial call to arthrex on 9/25/2019 the patient had no information on the products used or the facility involved.The patient indicated that the surgeon informed her that he had reported the incident to his sales rep.The patient also reported that the surgeon had informed her that the explanted devices had been turned over to the rep for return for evaluation.On 12/30/19 the patient provided the address of the original and revision surgeries.Using the address arthrex was able to obtain the original sales order from the (b)(6) 2019 procedure which identified the devices used in surgery.It was also determined at this time that the incident had not been previously reported to arthrex by the surgeon or sales representative.The following were the device part numbers of the plate and screws which were explanted on (b)(6) 2019: ar-8956-01, universal 5th metarsal hook plate, lot 047411909, ar-8724-14, low profile screw 2.4 x 14mm, lot 202634, ar-8724-22, low profile screw 2.4 x 22mm, lot 170630, ar-8724v-12, 2.4 x 12mm val screw, lot 2643582, ar-8724v-14, 2.4 x 14mm val screw, lot 187552, ar-8724v-16, 2.4 x 16mm val screw, lot 1048059, ar-8724v-16, 2.4 x 16mm val screw, lot 2643602.Additional information obtained 12/31/19: the sales rep confirmed that at no time were the explanted devices turned over to him, nor did the surgeon request that the devices be evaluated.Additional information obtained "1/8/30": the sales rep has confirmed with the facility that they did not keep the explanted devices as no one had requested that the devices be kept.Additional information obtained 1/22/20: the sales representative confirmed that the surgeon advised him that he did not tell the patient he gave the implants to the sales rep.The surgeon did confirm that the nurses discarded the plate implant and screws.

• Brand Name: UNIVERSAL 5TH METARSAL HOOK PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9635990
• Report Number: 1220246-2020-01619
• Device Sequence Number: 2791450
• Product Code: HRS
• UDI-Device Identifier: 00888867055636
• UDI-Public: 00888867055636
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: UNIVERSAL 5TH METARSAL HOOK PLATE
• Device Catalogue Number: AR-8956-01
• Device Lot Number: 047411909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other