MAUDE Adverse Event Report: ARTHREX, INC. SHAVERDRILL FOR 2.4MM PUSHLOCK, SHORT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number SHAVERDRILL FOR 2.4MM PUSHLOCK, SHORT

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

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 during a shoulder arthroscopy surgery the device produced metal chips inside the patient.No fragments remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint confirmed.Visual evaluation showed circumferential grooves at different locations along the shaft , consistent with sites of metal debris production.Critical dimension on the od shaft was measured and it was found to be in within specifications.The cause of this event is undetermined; however, a most likely cause is the prying and/or leveraging the device during use, resulting in the interference between the device and other instruments.

• Brand Name: SHAVERDRILL FOR 2.4MM PUSHLOCK, SHORT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 12507702
• MDR Text Key: 273587310
• Report Number: 1220246-2021-03690
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867291805
• UDI-Public: 00888867291805
• 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,Followup
• Report Date: 12/21/2021

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 Expiration Date: 07/31/2023
• Device Model Number: SHAVERDRILL FOR 2.4MM PUSHLOCK, SHORT
• Device Catalogue Number: AR-2922DSR-24
• Device Lot Number: 10228025
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1