ADSON DISSECT HK BLT 7.75"
Received Feb 21, 2019 · Event occurred Jan 30, 2019
Report 3011137372-2019-00055 · MDR key 8358430
Device
Generic name
Hook, Surgical, General & Plas
Manufacturer
Teleflex MedicalCatalog number
SURGICAL UNKNOWN
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT THE ITEM LISTED IS THE CLOSEST BASED ON THE CUSTOMER DESCRIPTION AS NO MODEL NUMBER IS GIVEN AND SAID IT IS AT LEAST 6 YEARS OLD. DURING A SURGICAL PROCEDURE ON THE SPINE THE TIP OF NERVE RETRACTOR FELL OFF INTO THE CAVITY. THERE WAS NO INJURY TO THE PATIENT AND THE TIP WAS EXTRACTED WITH NO ISSUE.
Additional Manufacturer Narrative
QN#(B)(4). THE DEVICE WAS DISCONTINUED GREATER THAN 10 YEARS AGO WHICH EXCEEDS OUR DOCUMENT RETENTION PERIOD. (1) SAMPLE OF 185700 WAS RECEIVED FOR EVALUATION. THIS PRODUCT WAS DISCONTINUED >10 YEARS AGO AND HAS EXCEEDED IT'S EXPECTED LIFE. VISUAL EVALUATION OF THE TIP NOTED A FRACTURE PLAN SUGGESTIVE OF SHEERING FORCE. NO CORROSION OR DEFICIENCIES OF THE METAL WERE OBSERVED. NO FURTHER EVALUATION IS REQUIRED.
Description of Event or Problem
IT WAS REPORTED THAT THE ITEM LISTED IS THE CLOSEST BASED ON THE CUSTOMER DESCRIPTION AS NO MODEL NUMBER IS GIVEN AND SAID IT IS AT LEAST 6 YEARS OLD. DURING A SURGICAL PROCEDURE ON THE SPINE THE TIP OF NERVE RETRACTOR FELL OFF INTO THE CAVITY. THERE WAS NO INJURY TO THE PATIENT AND THE TIP WAS EXTRACTED WITH NO ISSUE.