MAUDE Adverse Event Report: Arthrex, Inc. 1.60MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.60MM DRILL FOR FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the tip of the drill broke off and remained inside the patient´s bone.The broken piece is located under the anchor in the bone.This was discovered during the computer tomography after the surgery.No further information was received.*** update 15-sep-2026 - further information was received: the incident occurred during the shoulder surgery.The broken-off piece is intended to remain in the patient permanently and the broken piece is firmly embedded in the bone because it is secured by the anchor.The surgery was finished successfully without using a different device.It was not necessary to switch the surgical technique.No second surgery was performed, and no revision surgery is planned.The patient underwent one postoperative computer tomography scan of the shoulder.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 1.60MM DRILL FOR FIBERTAK
• Common Device Name: DRILL BIT
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50867635
• Report Number: 1220246-2026-04863
• Device Sequence Number: 10661395
• Product Code: HTW
• UDI-Device Identifier: 00888867101906
• UDI-Public: (01)00888867101906(10)022339
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/23/2026

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: 1.60MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-1
• Device Lot Number: 022339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown