DILATOR, 7.1 X 190MM
Received Nov 26, 2024 · Event occurred Oct 11, 2024
Report 1220246-2024-08649 · MDR key 20787980
Device
Generic name
Dilator
Manufacturer
Arthrex, Inc.Model number
DILATOR, 7.1 X 190MMCatalog number
AR-S6524-071-190
Lot number
01583062
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-S6524-041-220, AR-S6524-051-210, AR-S6524-060-200, AND AR-S6524-071-190 DILATOR IS CHIPPED AND BENT AFTER REPEATED USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.