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

Model Number	RETROBUTTON DRILL PIN II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-04994
• Device Sequence Number: 5245936
• Product Code: LXH
• UDI-Device Identifier: 00888867019881
• UDI-Public: 00888867019881
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: RETROBUTTON DRILL PIN II
• Device Catalogue Number: AR-1595
• Device Lot Number: 14604706
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown