MAUDE Adverse Event Report: ARTHREX, INC. LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD; BONE FIXATION PLATE

Model Number	LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2023
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) 2023, it was reported by a sales rep via email concerning 2 pieces of ar-8840c-45, low profile screw¿, ss, 4.0 x 45 mm, cannulated, short thread.For 1 of the ar-8840c-45, its screw head was stripped.Both were eventually removed from the patient due to reduction loss.This occurred during a left open reduction internal fixation ankle fracture procedure on (b)(6) 2023.As part of a left ankle orif (also including plate and syndesmosis tightropes), surgeon attempted to insert 2x 4.0mmx 45mm short-thread cannulated screws ar-8840c-45 into the medial side of the ankle.Per technique, the surgeon first used 1.35mm guide wire ar-8943-01, guide wire, trocar tip, 1.35 mm x 130 mm, then overdrilled with a ar-8943-02, drill bit, cannulated, 2.6 mm.When inserting the screw using the ar-8943-12, drive shaft, cannulated, qc, t15 hexalobe per surgical technique, the surgeon stated that she was unable to advance the screw properly as the driver shaft was not engaging properly with the screw.For the second identical screw, the surgeon switched to the ar-8943-09, screwdriver, t15 hexalobe, cannulated and the surgeon stated that this screw advanced more successfully.Upon imaging, the surgeon then removed both screws and stated that she had lost reduction due to the first driver shaft not engaging properly.The surgeon also stated that the first screw head was stripped due to the first driver shaft not engaging properly.The surgeon decided to abort inserting screws into the medial side of the ankle as the patient was too swollen to continue.
Additional Manufacturer Narrative
Additional information: g3, h6.The complaint allegation is not confirmed.The device was not received for evaluation.No pictures were submitted.The bone quality encountered during the procedure were not provided.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD
• Common Device Name: BONE FIXATION PLATE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17824951
• Report Number: 1220246-2023-07992
• Device Sequence Number: 6124893
• Product Code: HWC
• UDI-Device Identifier: 00888867048072
• UDI-Public: 00888867048072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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 Model Number: LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD
• Device Catalogue Number: AR-8840C-45
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown