MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE PIP - BENT 16MM - W/INSTR; PIN, FIXATION, SMOOTH

Model Number	DYNANITE PIP - BENT 16MM - W/INSTR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
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
On (b)(6) 2022, it was reported by sales representative via email that an ar-4158ds-16b dynamite hammertoe screw ended up chewing away at the bone canal and it was not secure.Surgeon analyzed the inserter and realized the implant was placed on the inserter incorrectly, the bent portion was facing the wrong way.This did not allow the screw to be inserted straight, causing the failure at the bone canal during.This was discovered during a procedure on (b)(6) 2022.Additional information received on 5/31/2022: this was discovered during a hammertoe procedure and completed with the same ar-4158ds-16b dynamite device by inserting the dynamite hammertoe portion and using a k-wire to pin the toe since it destroyed the middle phalanx due to being on the inserter in the opposite direction.Nothing broke inside the patient and no further issues has been reported.

• Brand Name: DYNANITE PIP - BENT 16MM - W/INSTR
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: 14829197
• Report Number: 1220246-2022-05147
• Device Sequence Number: 4794464
• Product Code: HTY
• UDI-Device Identifier: 00888867310032
• UDI-Public: 00888867310032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: DYNANITE PIP - BENT 16MM - W/INSTR
• Device Catalogue Number: AR-4158DS-16B
• Device Lot Number: 13668272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/27/2022
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown