CORTICAL LOCKING SCREW

Report

Report Number: 0001825034-2018-03062
Event Type: Malfunction
Date Received: April 27, 2018
Date of Event: April 2, 2018
Report Date: November 28, 2018
Manufacturer: ZIMMER BIOMET, INC.
Product Code: HRS
PMA / PMN Number: PK143697
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 0

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03062-1; 0001825034-2018-03063-1. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. FTIR ANALYSIS CONDUCTED ON THE FOREIGN MATERIAL IN THE PACKAGE IDENTIFIED THAT IT IS CONSISTENT WITH THE FTIR SPECTRA OF CELLULOSE/COTTON. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO MANUFACTURING DEFICIENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem · 0

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). REPORTER HAD INDICATED THAT PRODUCT WILL BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT FOREIGN SUBSTANCES WERE INSIDE OF THE STERILE PACKAGES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310732	CORTICAL LOCKING SCREW	PLATE, FIXATION	HRS	ZIMMER BIOMET, INC.	N/A	807770

Patients

Seq	Age	Sex	Outcome	Treatment
1