MAUDE Adverse Event Report: ARTHREX, INC. FIXED ANGLE DRILL GUIDE, 2.8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number FIXED ANGLE DRILL GUIDE, 2.8MM

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

On 8/8/2023, it was reported by a sales representative via sems that an a0381-000 fixed angle drill guide had an issue.The surgeon bent the tip of the drill sleeve trying to thread it into the plate.The drill would not pass smoothly through the sleeve.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.

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.

• Brand Name: FIXED ANGLE DRILL GUIDE, 2.8MM
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17699684
• MDR Text Key: 322851404
• Report Number: 1220246-2023-07809
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIXED ANGLE DRILL GUIDE, 2.8MM
• Device Catalogue Number: 0381-000
• Device Lot Number: 220445
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2023
• Date Device Manufactured: 04/25/2022
• 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