FDA.reportPublic FDA data

MAUDE MDR 8252636

MDR report key
8252636
Report number
9680825-2019-00001
Event key
0
Event type
3
Date of event
2018-12-07
Date received
2019-01-16
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
1ULTRASONIC GENERATOR 230V CEULTRASONIC GENERATOR 230V CEORTHOFIX SRLJDXOS3000OS30003G4016Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-160

Event Narratives#

N

Patient 1

TECHNICAL EVALUATION: ON JULY 2017 ORTHOFIX (B)(4) ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX (B)(4) IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. THE RETURNED DEVICES, RECEIVED ON DECEMBER 24, 2018, WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICES WERE VISUALLY CHECKED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT AND THEN SENT TO THE SUPPLIER, (B)(4), FOR THE FUNCTIONAL CHECK. THE VISUAL CHECK EVIDENCED AS FOLLOWS: THE CASE FRAME OF THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4), IS DAMAGED. THE CONNECTOR OF THE CABLE CODE CH300 LOT CH2310 IS STRONGLY DAMAGED. THE FUNCTIONAL CHECK EVIDENCED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY WITH THE EXCEPTION OF THE LED OF THE CHANNEL 1 THAT IS BURNED. THE CABLE, DEVICE CODE CH300 BATCH CH2310, IS NOT FUNCTIONING PROPERLY. THE SEALING IS LOST FROM THE CONNECTOR AND THE EARTH BOND TEST FAILED. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. THE FAILURE FOUND ON THE LED OF THE CHANNEL 1 CAN BE CONSIDERED NORMAL WEAR AND TEAR OF THE ELECTRICAL COMPONENTS. THE FAILURE FOUND ON THE CABLE, DEVICE CODE CH300 BATCH CH2310, IS MOST LIKELY ATTRIBUTABLE TO AN ACCIDENTAL CRUSHING OF THE CONNECTOR. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED: "IN THIS CASE AN OSCAR GENERATOR AND CABLE WERE FOUND TO BE NOT FUNCTIONAL. WE DO NOT KNOW WHAT THE INTENDED PROCEDURE WAS. THE OPERATION HAD TO BE PERFORMED WITH ONE HANDSET AND CABLE AND ONE CHANNEL. ALL THE NORMAL PROCEDURES WOULD HAVE BEEN POSSIBLE BUT IT ALL TOOK LONGER THAN WAS EXPECTED, TO THE EXTENT THAT THE OPERATING TIME WAS EXTENDED BY A CLINICALLY RELEVANT, BUT UNSPECIFIED AMOUNT. NO FURTHER INFORMATION IS PROVIDED. THE TECHNICAL REPORT HAS HIGHLIGHTED 2 SMALL MARKS ON THE GENERATOR CASING. THE GENERATOR FUNCTIONS PERFECTLY WELL WITH ONE EXCEPTION: THE LED ILLUMINATING THE CHANNEL 1 SCREEN HAS BLOWN AND DOES NOT WORK. IT IS THEREFORE IMPOSSIBLE TO USE CHANNEL 1. IN ADDITION TO THIS THE ASSOCIATED CABLE IS 'UNUSABLE' BECAUSE OF A DAMAGED CONNECTOR AND A FAILED EARTH BOND TEST. THE CONNECTOR HAS BEEN DAMAGED DUE TO ROUGH HANDLING, AND THE LED FAILED BECAUSE THESE COMPONENTS DO FAIL EVENTUALLY. THE OPERATION WAS COMPLETED AS PLANNED BUT CONSIDERABLE TIME (UNSPECIFIED) WAS LOST". FINAL COMMENTS: BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AN ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO NORMAL WEAR AND TEAR OF THE ELECTRICAL COMPONENTS OF THE GENERATOR. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2019-00002.

D

Patient 1

THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES INVOLVED: 1 ULTRASONIC GENERATOR 230V CE CODE OS3000 BATCH (B)(4) (MFR REPORT) AND 1 CABLE CODE CH300 BATCH CH2310 (MFR 9680825-2019-00002). HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON'S NAME: NO RESPONSE. DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE. SURGERY DESCRIPTION: OTHER. PATIENT INFORMATION: NO RESPONSE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "IT APPEARS 1 X HANDSET IS NOT FUNCTIONING AND 1 X CABLE IS NOT WORKING. IT SEEMS THAT FRIDAY'S CASE WAS AN EXCEPTIONAL ONE AND NOT THE CASE FOR OSCAR TO FAIL IN. THEY HAVE A 'STEWARD'S INQUIRY' GOING ON QUESTIONING WHY A SET FRESH FROM SERVICE DID NOT FUNCTION IN A CRITICAL CASE. WHILST STAFF WERE CALM TODAY IT SEEMS RED FACES AND BAD TEMPERS WERE ABOUND ON FRIDAY". THE COMPLAINT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. 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. INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION IS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED. (B)(4).