MAUDE Adverse Event Report: ARTHREX, INC. 2.7MM SCREW DEPTH INDICATOR; DEPTH GAUGE

Model Number 2.7MM SCREW DEPTH INDICATOR

Device Problem Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 09/05/2023

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the length measurement did not work properly and therefore wrong screws were chosen.There was no harm for patient, operator or third party reported.No further information received.***update 13-sep-2023 nroe: further information revealed that this incident occurred during a clavicle fracture treatment with a distal clavicle plate.There was no harm for patient, operator or third party.The surgery was finished successfully after replacing the screws that were to long with shorter screws.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 2.7MM SCREW DEPTH INDICATOR
• Type of Device: DEPTH GAUGE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17864205
• MDR Text Key: 324841643
• Report Number: 1220246-2023-08060
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00888867098534
• UDI-Public: 00888867098534
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.7MM SCREW DEPTH INDICATOR
• Device Catalogue Number: AR-2670
• Device Lot Number: 1068642103
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2023
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1