FDA.reportPublic FDA data

MAUDE MDR 8526211

MDR report key
8526211
Report number
9680825-2019-00025
Event key
0
Event type
3
Date received
2019-04-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ROBERTO DONADELLO
Address
VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GOTFRIED PC.C.P. NECK SCREW DRIVERGOTFRIED PC.C.P. NECK SCREW DRIVERORTHOFIX SRLJDO184000184000AD0528R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1801. R

Event Narratives#

N

Patient 1

TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ON GOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION AND/OR FURTHER INFORMATION ON THE CASE ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

D

Patient 1

THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: N/A. BODY PART TO WHICH DEVICE WAS APPLIED: N/A. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE INNER SHAFT IN THE DRIVER IS TOO LONG AND POPPING OUT WITHOUT PUSHING THE BUTTON ON TOP THUS ITS IMPOSSIBLE TO ASSEMBLE/DISASSEMBLE IT AFTER INSERTION. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 40 MINUTES DELAY. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: UNKNOWN. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON APRIL 15, 2019: "REGARDING PATIENT DETAILS, AS FAR AS I KNOW THE PATIENT RECOVERS AND THIS ISSUE DIDN'T AFFECT HER AT ALL. I DON'T HAVE ANY DETAILS ABOUT HER AGE OR WEIGHT." MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: N/A.