MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM S-TAK PERC INSERT DISP KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number 2.4MM S-TAK PERC INSERT DISP KIT

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

On 06/20/2023, it was reported by a arthrex employee via sems that an ar-1934pi perc insert kit drill bit bent and became stuck inside the guide.This was discovered during a case with no patient effect.

• Brand Name: 2.4MM S-TAK PERC INSERT DISP KIT
• 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: 17350853
• MDR Text Key: 319975848
• Report Number: 1220246-2023-07212
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867024137
• UDI-Public: 00888867024137
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.4MM S-TAK PERC INSERT DISP KIT
• Device Catalogue Number: AR-1934PI
• Device Lot Number: 14981861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/19/2023
• Date Device Manufactured: 07/15/2022
• 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