FDA.reportPublic FDA data

MAUDE MDR 7747962

MDR report key
7747962
Report number
2939274-2018-53185
Event key
0
Event type
3
Date received
2018-08-03
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#

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 LLCHTC388.50Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-030

Event Narratives#

N

Patient 1

NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DHR REVIEW WAS COMPLETED. PART # 388.50 ; SYNTHES LOT # 3914478; SUPPLIER LOT # A7HA29; RELEASE TO WAREHOUSE DATE: 28JAN1999; SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE AND REPAIR CONDUCTED AN EVALUATION OF THE RETURNED DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS BENT AND THE COLLAR WOULD NOT FIT. DEVICE HISTORY RECORD(S) REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE AND REPAIR EVALUATION: THE REPAIR TECHNICIAN REPORTED THE TUBE AND COLLET WERE BENT AND DAMAGED. BENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: TUBE, NUT, COLLET, DOG POINT SET SCREW. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 27-JUN-2018 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. CONCLUSION: 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 ROUTINE INSPECTION ON JUNE 13, 2018, IT WAS DISCOVERED THAT THERE WERE MALFUNCTIONS ON FIVE (5) DIFFERENT INSTRUMENTS. THE TUBE OF TWO (2) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE DISCOVERED BENT AND THE COLLAR WOULD NOT FIT. IN ADDITION, IT WAS ALSO NOTED THAT THE SECURING PIN ON THE HANDLE FOR HOOK/SCREW HOLDER WAS STARTING TO COME OUT RESULTING TO NOT ACCEPTING THE HOLDER SCREW. THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANT WAS ALSO NOTED TO BE BROKEN OR CRACKED. AND THE THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS WAS ALSO FOUND STRIPPED AND DID NOT THREAD ON THE SCREW EASILY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN COLLAR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREW HOLDER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 2 FOR (B)(4).