MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 12MM; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 12MM
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2019
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 that the surgeon had to remove the wrist spanning plate, ar-8916spn, because the screws were not locked into the distal holes.No further information, additional information requested.Additional information provided 12/18/2019: case date of implantation: (b)(6) 2019, case date of explantation: not yet determined.The following screws were also explanted during the revision: ar-8724-10 lot: 1058931, ar-8724v-10 lot: w654331, ar-8724v-16 lot: w630941, ar-8935-12 lot: 10220124, ar-8935l-12 lot: 10248943, ar-8935l-12 lot: 10257929.Note: the specific date of the second surgery (explant) is unknown, however it is known that the date was prior to (b)(6) 2019.For reporting purposes (b)(6) 2019 has been entered as the date of event.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9570060
• Report Number: 1220246-2020-01565
• Device Sequence Number: 438743
• Product Code: HWC
• UDI-Device Identifier: 00888867131934
• UDI-Public: 00888867131934
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: LO-PRO SCRW,TI,3.5MMX 12MM
• Device Catalogue Number: AR-8935-12
• Device Lot Number: 10220124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/09/2020
• 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