MAUDE Adverse Event Report: ARTHREX, INC. RETROBUTTON DRILL PIN II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number RETROBUTTON DRILL PIN II

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

It was reported that during a surgery after the surgeon used the retrobutton drill pin, it was noticed that there was small metal debris around it at the level of the arthroscopy image.The surgeon performed a suction and wash of the surgical site to remove the debris.No further information received.

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.

Manufacturer Narrative

Complaint confirmed.One ar-1595 batch # 14604706 was received for investigation.Visual evaluation noticed circumferential marks/scratches around outer diameter (od) surface of the device.This indicates interference between the drill pin and the drill guide.Without additional information, the cause remains undetermined.However, a probable cause could be attributed to prying or leveraging forces applied to the drill pin, resulting in interference and potentially generating metal debris.Refer to investigation pictures # 1-5.

• Brand Name: RETROBUTTON DRILL PIN II
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14548030
• MDR Text Key: 300778993
• Report Number: 1220246-2022-04994
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867019881
• UDI-Public: 00888867019881
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETROBUTTON DRILL PIN II
• Device Catalogue Number: AR-1595
• Device Lot Number: 14604706
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1