FDA.reportPublic FDA data

MAUDE MDR 9348937

MDR report key
9348937
Report number
9610612-2019-00795
Event key
0
Event type
3
Date of event
2019-10-17
Date received
2019-11-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS KERSTIN ROTHWEILER
Address
PO BOX 40 TUTTLINGEN, 78501 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CASPAR RONGEURUP-BITESERR 3MM160MMBONE PUNCHES, RONGEURSAESCULAP AGHTXFF543RFF543RY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-200

Event Narratives#

N

Patient 1

MANUFACTURING SITE EVALUATION: PRODUCT HAS BEEN RECEIVED FOR INVESTIGATION, FELL OFF MOUTH PART SENT IN TOGETHER WITH INSTRUMENT. THE INSTRUMENT IS IN A DECONTAMINATED CONDITION. ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. THE INSTRUMENTS UPPER MOUTH PART IS BROKEN INVESTIGATION: VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. DURING INVESTIGATION THE BREAKAGE SURFACES OF THE BROKEN MOUTH PART AND THE REMAINED PART ON THE INSTRUMENT HAVE BEEN ANALYSED. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONALE: ACCORDING TO THE INVESTIGATION RESULTS A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. BASED ON THE ANALYSIS OF THE BREAKAGE SURFACE, MOST PROBABLY THE BREAKAGE WAS CAUSED BY AN OVERLOAD SITUATION DURING THE SURGERY. CORRECTIVE ACTION: CORRECTIVE ACTION AND PREVENTIVE ACTION IS NOT NECESSARY.

D

Patient 1

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH RONGEUR CASPAR . IT WAS REPORTED THAT ONE OF THE GRASPING PARTS BROKE OFF DURING OPERATION. THE INSTRUMENT WAS NOT BEING USED ON HARD TISSUE OR BONE. THE BROKEN PART WAS IMMEDIATELY REMOVED WITHOUT PROBLEMS. THERE WAS NO PATIENT HARM. AN ADDITIONAL MEDICAL INTERVENTION WAS NOT NECESSARY. THERE WAS NO SURGERY DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER (B)(4).