MAUDE Adverse Event Report: ARTHREX, INC. STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK; DRILL BIT

Model Number	STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On 24th july 2024, it was reported by an arthrex employee via email that an ar-1250lt, step drill for 3.0mm bio-suturetak®, was used to punch holes into the bone to facilitate screw insertion however the drill bit broke during drilling and about 15mm of the broken drill bit remained in the shoulder blade.This was detected during use in a repair of the right shoulder joint capsule and lip surgery on (b)(6) 2019.There was no adverse effect on the patient's original condition, but it may not be possible to perform magnetic resonance examination in the future.It was reported to nmpa as adverse events by hospital.The procedure was completed successfully with the only issue being that the broken piece was left in the patient.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.(b)(4).

• Brand Name: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Common Device Name: DRILL BIT
• 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: jared engle ; 8009337001
• MDR Report Key: 19943932
• Report Number: 1220246-2024-07112
• Device Sequence Number: 7319498
• Product Code: HWE
• UDI-Device Identifier: 00888867006287
• UDI-Public: 00888867006287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/08/2024

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: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Device Catalogue Number: AR-1250LT
• Device Lot Number: 851977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown