FDA Adverse Event Malfunction Summary report: N

STANDARD WISHBONE ASSEMBLY

MDR report key: 10585409 · Received September 25, 2020

Report

Report Number: 2125289-2020-00001
Event Type: Malfunction
Date Received: September 25, 2020
Report Date: August 27, 2020
Manufacturer: INTEGRA LIFESCIENCES CORPORATION OH/USA
Product Code: GAD
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION; HOWEVER A VIDEO WAS PROVIDED BY THE CUSTOMER. DEVICE HISTORY RECORD (DHR) - RECORD NOT AVAILABLE AS NO LOT OR SERIAL NUMBER WAS PROVIDED. REVIEW OF THE VIDEO CONFIRMS THE REPORTED INSTABILITY. HOWEVER, ROOT CAUSE CANNOT BE DETERMINED, SINCE PRODUCT HAS NOT RETURNED FOR EVALUATION AND NO LOT OR SERIAL NUMBERS HAVE BEEN PROVIDED, WHICH COULD DETERMINE THE AGE AND POSSIBLY THE MAINTENANCE HISTORY OF THE DEVICE. IF PRODUCT DOES RETURN, THIS COMPLAINT CAN BE REOPENED AND REEVALUATED. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH FAILURE ANALYSIS. THERE WERE NO ADVERSE TRENDS DISCOVERED FOR THIS ISSUE, AND THE RISK IS ACCEPTABLE, THEREFORE NO FURTHER INVESTIGATION OR ACTION IS REQUIRED.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

A CUSTOMER REPORTED THAT THE WISHBONE FRAME OF THE 4020 STANDARD WISHBONE ASSEMBLY WAS HAVING INSTABILITY COMPLAINT IN LOCKING CONDITION. THERE WAS NO PATIENT INVOLVEMENT AND NO KNOWN SURGERY DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1055206	STANDARD WISHBONE ASSEMBLY	SURGICAL RETRACTOR	GAD	INTEGRA LIFESCIENCES CORPORATION OH/USA

Patients

Seq	Age	Sex	Outcome	Treatment
1