2.4MM BIO-SUTURETAK DISPOSABLES KIT
Received Jun 5, 2026 · Event occurred Mar 17, 2026
Report 1220246-2026-03257 · MDR key 25416569
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
2.4MM BIO-SUTURETAK DISPOSABLES KITCatalog number
AR-1934-24DS
Lot number
15569611
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 20-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1934-24DS 2.4 MM BIO-SUTURETAK® DISPOSABLE KIT WAS OPENED FOR A CASE AND THE DRILL IMMEDIATELY SNAPPED WHEN PLACED IN THE DRILL SLEEVE FROM THE KIT. ADDITIONAL INFORMATION WAS PROVIDED ON 27-MAY-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE DEVICE SNAPPED WHEN PLACED IN THE AR-1934-24DS DRILL SLEEVE FROM THE KIT. ALL FRAGMENTS WERE RETRIEVED. A REUSABLE DRILL TRAY WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION WAS PROVIDED ON 28-MAY-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THIS EVENT OCCURRED DURING A HIP SCOPE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.