MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,TRIM-IT SPIN PIN; PIN, FIXATION, SMOOTH

Model Number	IMPL DELIVERY SYS,TRIM-IT SPIN PIN
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The surgeon agreed to trial the trim-it spin pins for pip fusions.During the case, after he trimmed the pin and inserted it in the toe, he held it with an artery clip and activated the drill to break the pin.However, instead of the pin breaking at the break-off point, the pin broke at the point where the artery clip was holding it.This happened multiple times during the case.

• Brand Name: IMPL DELIVERY SYS,TRIM-IT SPIN PIN
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12393470
• Report Number: 1220246-2021-03588
• Device Sequence Number: 4181493
• Product Code: HTY
• UDI-Device Identifier: 00888867032859
• UDI-Public: 00888867032859
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Health Professional
• Device Model Number: IMPL DELIVERY SYS,TRIM-IT SPIN PIN
• Device Catalogue Number: AR-4156DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1