FDA.reportPublic FDA data

MAUDE MDR 7057920

MDR report key
7057920
Report number
9611112-2017-00005
Event key
0
Event type
3
Date of event
2017-08-29
Date received
2017-11-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. THOMAS BUTSCH
Address
BADSTRASSE 8 TUTTLINGEN, 78532 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEWIN BONE HOLD CLAMP 7CLAMPHEBUMEDICAL GMBHGDJ225175100088-1607R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-2401. R

Event Narratives#

N

Patient 1

RETURN OF THE DEVICE WAS REQUESTED, BUT IT HAD BEEN SCRAPPED AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION AND TESTING. EVALUATION WAS BASED ON A PHOTOGRAPH OF THE DAMAGED DEVICE AND MANUFACTURING RECORDS. IT WAS MANUFACTURED IN JULY 2016. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. THE PHOTOGRAPH OF THE DEVICE CONFIRMED BREAKAGE OF THE TIP AND SIGNS OF WEAR. INAPPROPRIATE USE OF THE DEVICE BY APPLICATION OF EXCESSIVE FORCE TO THE TIPS OF THE INSTRUMENT MAY HAVE CAUSED THE FRACTURE. HOWEVER, SINCE THE DEVICE WAS NOT RETURNED IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS FAILURE.

D

Patient 1

THE SURGEON WAS USING THE LEWIN CLAMP DURING A RIGHT TOTAL HIP ARTHROPLASTY TO CLAMP DOWN ON PATIENT'S BONE AND THE ENTIRE TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO HARM TO PATIENT.