MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER, DRIVE SHAFT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 02/18/2025, it was reported by a sales representative via (b)(4) that an ar-9597-10 angled reamer sleeve, 10° and an ar-9676 angled reamer, drive shaft fused together during surgery.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9676 with an unknown batch was received for evaluation.The device arrived for evaluation, stuck inside the ar-9597-10 batch 3762223.The visual evaluation revealed nicks on the hudson connector.Functional testing cannot be performed as the device has the ar-9676 stuck inside the ar-9597-10 batch 3762223.The most likely cause for the reported failure can be attributed to misuse due to a force perpendicular to the drive shaft being applied while the device is spinning.This applied force creates an excess of friction and heat that ultimately has the potential to cause the device to seize from functioning as intended.Application of this force perpendicular to the drive shaft is not needed for the device to function, nor is it recommended that the user do this during normal clinical use.When used normally, this issue is unlikely to present itself, which suggests that the handling of the device has a large impact on whether or not it will seize.For this reason, the direct cause is considered to be misuse of the device.
Event or Problem Description
Additional information was received on 03/31/2025: this was discovered during a reverse total shoulder procedure on (b)(6) 2025.They opened a backup tray with ar-9597-10 and ar-9672 to complete the case.The case was delayed by one minute, with minimal anesthesia administered to the patient.No adverse effects on the patient were reported.

• Brand Name: ANGLED REAMER, DRIVE SHAFT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21470932
• Report Number: 1220246-2025-00690
• Device Sequence Number: 3567746
• Product Code: LXH
• UDI-Device Identifier: 00888867324954
• UDI-Public: 00888867324954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: ANGLED REAMER, DRIVE SHAFT
• Device Catalogue Number: AR-9676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown