MAUDE Adverse Event Report: ARTHREX, INC. LOCKING STRAIGHT PLATE, 22, 10H; WASHER, BOLT NUT

Model Number	LOCKING STRAIGHT PLATE, 22, 10H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2017
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 that on (b)(6) 2017 the patient underwent an ankle fracture procedure where the following devices were implanted: ar-8943c-10 / lot: 1338539 x1.Ar-8835-20 / lot: 10016008 x1.Ar-8835l-14 / lot: 141751 x1.Ar-8835l-16 / lot: 10003529 x3.Ar-8835l-18 / lot: 1382955 x3.Ar-8926t / lot: 17469 x1.Patient underwent a second procedure on (b)(6) 2019 for an unknown reason.All devices listed above were explanted.
Additional Manufacturer Narrative
Additional information was received 4/24/2019.The event description has been updated to reflect this additional information.There were no allegations against the device.The device was returned partly damaged which was most likely caused by the explantation of the device.The device was found to meet specifications.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient underwent an ankle fracture procedure where the following devices were implanted: ar-8943c-10 / lot: 1338539 x1, ar-8835-20 / lot: 10016008 x1, ar-8835l-14 / lot: 141751 x1, ar-8835l-16 / lot: 10003529 x3, ar-8835l-18 / lot: 1382955 x3, ar-8926t / lot: 17469 x1.Patient underwent a second procedure on (b)(6) 2019 for an unknown reason.All devices listed above were explanted.Additional information provided 4/24/2019: the second surgery was confirmed and the devices listed were explanted.Patient was operated and titanium implants were placed to replace the explanted steel implants.It was reported that the products were withdrawn in the second surgery for safety and to avoid metallosis.No further explanation was provided as to any additional reason for the second surgery.

• Brand Name: LOCKING STRAIGHT PLATE, 22, 10H
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8526635
• Report Number: 1220246-2019-01042
• Device Sequence Number: 1871216
• Product Code: HTN
• UDI-Device Identifier: 00888867052642
• UDI-Public: 00888867052642
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: LOCKING STRAIGHT PLATE, 22, 10H
• Device Catalogue Number: AR-8943C-10
• Device Lot Number: 1338539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other