MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 14MM; SCREW, FIXATION, BONE

Model Number LO-PRO SCRW,TI,3.5MMX 14MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/04/2019

Event Type  Injury  

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 Description

It was reported that the surgeon had to remove the wrist spanning plate, ar-8916spn, because the screws were backing out of 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-8724-12 lot: 2542021, ar-8724v-12 lot: 2605841, ar-8724v-18 lot: 2605831, ar-8935-14 lot: 10176201, ar-8935-14 lot:10249431.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 14MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9569945
• MDR Text Key: 189237709
• Report Number: 1220246-2020-01560
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867050402
• UDI-Public: 00888867050402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 14MM
• Device Catalogue Number: AR-8935-14
• Device Lot Number: 10176201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other