FDA.reportPublic FDA data

MAUDE MDR 7516703

MDR report key
7516703
Report number
2939274-2018-52194
Event key
0
Event type
3
Date of event
2018-03-19
Date received
2018-05-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL COTE
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTSPLIERS,SURGICALWRIGHTS LANE SYNTHES USA PRODUCTS LLCHTC388.50388.506946399Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-150

Event Narratives#

N

Patient 1

PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DHR REVIEW WAS COMPLETED. PART NUMBER: 388.50. SYNTHES LOT NUMBER: 6946399. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 24-JUL-2012. EXPIRATION DATE: N/A. MANUFACTURED BY (B)(4). NCR WAS GENERATED DURING PRODUCTION FOR 3 OF 13 PARTS MISSING CERTS. PAPERWORK WAS REWORKED AND ALL PASSED INSPECTION. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE IT IS NOT RELATED TO COMPLAINT CONDITION OF THE DEVICE NOT HOLDING WHILE THE INSTRUMENT WAS DEPRESSED, A CRACK IN THE SPRING OF THE DEVICE, AND ROD BENDER WITH BEND RADIUS ADJUSTMENT DEVICE WAS NOT WORKING PROPERLY AND MIGHT BE MISSING A SPRING. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE & REPAIR CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE PLIERS WERE NOT HOLDING, AND THE SPRING WAS CRACKED. THE REPAIR TECHNICIAN REPORTED THE SPRING WAS BROKEN, AND THE PLIERS WERE TOO TIGHT. LEAF/SPRING BROKEN IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: RATCHET, SPRING (SET). THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 10-MAY-2018 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 30. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN DOCUSPHERE DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

IT WAS REPORTED THAT DURING AN UNKNOWN SPINAL SURGERY ON (B)(6) 2018, IT WAS NOTED THE ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WAS NOT HOLDING WHILE THE INSTRUMENT WAS DEPRESSED. THERE WAS ALSO A CRACK NOTED IN THE SPRING OF THE DEVICE. DURING THE SAME PROCEDURE IT WAS NOTED THAT THE ROD BENDER WITH BEND RADIUS ADJUSTMENT WAS MISSING THE SPRING, WHICH PREVENTED THE DEVICE FROM TIGHTENING. BOTH DEVICES WERE SET ASIDE AND OTHER SIMILAR DEVICES WERE READILY AVAILABLE AND WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY AND NO PATIENT HARM. THE SERVICE AND REPAIR EVALUATION REVEALED THE SPRING ON THE ROD INTRODUCTION PLIERS WAS BROKEN AND THE PLIERS WERE TOO TIGHT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).