MalfunctionGAB

NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.248 STERILE

Received Jul 7, 2026

Report 3002750084-2026-00069 · MDR key 25737634

Device

Generic name

Suture Needle

Manufacturer

Aspen Surgical Products, Inc.

Model number

216704

Lot number

416429

Product problems

Break

Patient

Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "FREE SUTURE NEEDLE BROKE AT THE EYELET DURING USE. RIGHT MODIFIED MCLAUGHLIN PROCEDURE (SHOULDER)."