MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 20°; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER SLEEVE, 20°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/07/2025, a sales representative via (b)(4) reported that an ar-9597-20 angled reamer sleeve 20°, became bound while reaming a glenoid.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 04/21/2025: the angled reamer drive shaft became bound with the ar-9597-20 angled reamer sleeve 20°.At this time, the part and lot number of the angled reamer drive shaft is unknown.The case was completed by opening a backup arthrex augmented mgs instrument set.No case delay or added anesthesia was administered.No adverse effects were reported on or after the surgery.This occurred during a reverse total shoulder procedure on (b)(6) 2025.Additional information was received on 04/24/2025: the part and lot number of the angled reamer drive shaft are unknown, but it has functioned well with another angled reamer sleeve and has been returned to circulation.
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-9597-20, angled reamer sleeve, batch number 37622131, was received for investigation.Visual evaluation of the returned device noted nicks and striations in its inner diameter on both the proximal and distal ends.Functional testing was performed with a known good ar-9676, and it was noted that the device rotated as intended.No problem found.

• Brand Name: ANGLED REAMER SLEEVE, 20°
• 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: 21885568
• Report Number: 1220246-2025-01655
• Device Sequence Number: 15497450
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: (01)00888867343450(11)211129(10)37622131
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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 SLEEVE, 20°
• Device Catalogue Number: AR-9597-20
• Device Lot Number: 37622131
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided; 08/12/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/05/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown