LEG HOLDER, LOW PROFILE
Received Jul 22, 2024 · Event occurred Jun 25, 2024
Report 1220246-2024-06812 · MDR key 19791799
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
LEG HOLDER, LOW PROFILECatalog number
AR-1500
Lot number
00301.14
Product problems
- Naturally Worn
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, ACCORDING TO PICTURES, THE LEG HOLDER SHOWS SIGNS OF WEAR AND TEAR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
CORRECTIONS: H.1 SET AS N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON FURTHER REVIEW AND EVALUATION OF ASSOCIATED RISK DOCUMENTATION, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.
Description of Event or Problem
UPDATE, (KHE), (B)(6) 2024 FURTHER INFORMATION RECEIVED. THE EVENT WAS OCCURRED DURING THE REPROCESSING.