FDA.reportPublic FDA data

MAUDE MDR 3229145

MDR report key
3229145
Report number
3002806535-2013-00129
Event key
0
Event type
3
Date of event
2013-06-17
Date received
2013-07-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. SIAN ROGERS
Address
WATERTON INDUSTRIAL ESTATES BRIDGEND, SOUTH WALES CF31 UK
Phone
44-44-0441
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAWBLADESBLADE, SAW, GENERAL AND PLASTIC SURGERYBIOMET UK LTD.DZHN/AUNKNOWNUNKNOWNY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-1601. H; 2. R

Event Narratives#

N

Patient 1

PRODUCT WAS RETURNED AND EVALUATED. THE EVALUATION CONFIRMED THAT THE SAW BLADES IN THE KIT COULD ONLY BE USED FOR A CEMENTED PROCEDURE. THE SAWBLADES ARE GENERIC AND ARE CURRENTLY BEING EXCHANGED TO THE CORRECT VERSIONS. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. SEE ALSO: 3002806535-2013-00128.

D

Patient 1

IT WAS REPORTED THAT DURING A KNEE PROCEDURE ON (B)(6) 2013, AN OXFORD SHORT ROD INSTRUMENT AND THE CORRECT SAW BLADES WERE MISSING FROM THE LOANER KIT WHICH RESULTED IN A 30-45 MINUTE DELAY IN SURGERY. NO PATIENT INJURY WAS REPORTED.

N

Patient 1

THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PATIENT INJURY WAS REPORTED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. MANUFACTURE DATE - UNKNOWN. THIS IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR: 3002806535-2013-00128.