NERVE HOOK
Received Dec 10, 2014 · Event occurred Nov 1, 2014
Report 1417592-2014-00114 · MDR key 4336084
Device
Manufacturer
Medline Industries, Inc.Catalog number
MDG1163116
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE TIP OF THE HOOK BROKE OFF INSIDE OF A PT.
Additional Manufacturer Narrative
THE TIP OF THE HOOK BROKE DURING A SURGICAL PROCEDURE AND WAS NOT RETRIEVED. MULTIPLE ATTEMPTS WERE MADE TO GATHER INFO REGARDING THE ALLEGED INCIDENT AND NO RESPONSE WAS GIVEN. WE HAVE NO PHOTO OR LOT NUMBER. WE HAVE NO DETAILS REGARDING THE INCIDENT OR HOWE THE INSTRUMENT WAS BEING USED. WE HAVE NOT BEEN MADE AWARE OF ANY SERIOUS INJURY OR PT COMPLICATION RESULTING FROM THIS INCIDENT. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE. IN THE ABSENCE OF A SAMPLE OR PHOTOS TO EVALUATE, A ROOT CAUSE HAS NOT BEEN DETERMINED.