REPROCESSED ARTHREX MULTIFIRE SCORPION NEEDLE
Received Feb 22, 2017 · Event occurred Jan 17, 2017
Report 3032391-2017-00003 · MDR key 6349402
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ALTHOUGH MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE, IT WAS NOT RETURNED TO FOR EVALUATION. THEREFORE WE COULD NOT CONFIRM IF THE DEVICE WAS REPROCESSED. ADDITIONALLY, THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE REPROCESSING RECORDS COULD NOT BE PERFORMED. DUE TO THE LACK OF INFORMATION SURROUNDING THE INCIDENT, WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. IF MORE INFORMATION IS PROVIDED THEN THIS MDR WILL BE UPDATED. THERE WAS NO REPORT OF AN ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ARTHREX MULTIFIRE SCORPION NEEDLE, MODEL AR-13995N, DETACHED DURING USE. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE DETACHED TIP.