CORONOID PLATE RT STE

Report

Report Number: 0001825034-2016-02007
Event Type: Injury
Date Received: June 9, 2016
Date of Event: February 19, 2016
Report Date: May 10, 2016
Manufacturer: BIOMET TRAUMA
Product Code: HRS
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, "LOOSENING, BENDING, CRACKING OR FRACTURE OF ORTHOPEDIC SCREW, INTRAMEDULLARY NAIL, PLATE, AND SCREW-PLATE COMBINATION OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, MARKEDLY UNSTABLE COMMINUTED FRACTURES." THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET U.S. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K111663. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE AND CONFIRMED REPORTED CONDITION. ROOT CAUSE OF THE EVENT WAS MOST LIKELY OVER BENDING THE ARM IN ATTEMPTS TO POSITION THE ARM ON THE PLATE TO MATCH THE PATIENT¿S ANATOMY; HOWEVER, A CONCLUSIVE DETERMINATION COULD NOT BE MADE.

Description of Event or Problem · 1

DURING A PROCEDURE, THE PLATE FRACTURED AFTER BEING IMPLANTED IN THE PATIENT. THE PLATE WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 40 MINUTE DELAY IN PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364179	CORONOID PLATE RT STE	PLATE, FIXATION	HRS	BIOMET TRAUMA	N/A	363060

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention