MAUDE Adverse Event Report: ARTHREX, INC. BIO DELIVERY CANNULA - TROCHANTERIC NAIL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BIO DELIVERY CANNULA - TROCHANTERIC NAIL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
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 10/17/2025, it was reported by a sales representative via (b)(4) that an abs-1094 bio delivery cannula-trochanteric nail had no laser line on long 3.2 wire.This was discovered during the case with no patient harm.Additional information per rep was received 10/13/25 that the workaround involved sequential reaming to approximate the appropriate lag screw size.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is not confirmed due to the lack of photographic evidence of the device.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to a manufacturing issue.

• Brand Name: BIO DELIVERY CANNULA - TROCHANTERIC NAIL
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23462751
• Report Number: 1220246-2025-04972
• Device Sequence Number: 15699013
• Product Code: LXH
• UDI-Device Identifier: 00888867455870
• UDI-Public: (01)00888867455870(11)250501(17)300430(10)5056157413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/02/2026

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: BIO DELIVERY CANNULA - TROCHANTERIC NAIL
• Device Catalogue Number: ABS-1094
• Device Lot Number: 5056157413
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Patient Sex: Unknown