FDA Adverse Event Malfunction Summary report: Y

UNKNOWN_INSTRUMENTSTIRE_PRODUCT

MDR report key: 6980277 · Received October 26, 2017

Report

Report Number: 0001811755-2017-01982
Event Type: Malfunction
Date Received: October 26, 2017
Date of Event: September 1, 2017
Report Date: January 29, 2018
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: GFA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2013007. 1 EVENT WAS REPORTED FOR THIS QUARTER. 1 DEVICE RECEIVED FOR EVALUATION; A HAIR IN THE OPEN PACK WAS CONFIRMED. NO FURTHER EVALUATION WAS POSSIBLE AS THE PACK WAS ALREADY OPENED AND ITS NOT POSSIBLE TO DETERMINE WHEN THE HAIR ENTERED THE PACK. THERE WERE NO REMEDIAL ACTIONS TAKEN. THIS DEVICE IS LABELLED FOR SINGLE-USE.

Additional Manufacturer Narrative · 1

THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2013007. THE DEVICE IDS IN THIS REPORT WERE CITED AS EQJ. EQJ DOES NOT CORRELATE WITH THE PRODUCT CODE GFA IN THE ORIGINAL ACCEPTANCE LETTER. THE PRODUCT CODE FOR THESE DEVICES WERE RETURNED TO GFA TO ALIGN TO THE PRODUCT CODE IN THE ORIGINAL ACCEPTANCE LETTER AND REPORTED UNDER REPORT NUMBER 0001811755-2017-01979.

Description of Event or Problem · 1

THIS REPORT SUMMARIZES MALFUNCTION EVENT IN WHICH A HAIR WAS OBSERVED IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

Description of Event or Problem · 1

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH A HAIR WAS OBSERVED IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
761820	UNKNOWN_INSTRUMENTSTIRE_PRODUCT	BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL	GFA	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1