FDA Adverse Event Malfunction Summary report: N

VALIDATION TOOL

MDR report key: 6185625 · Received December 19, 2016

Report

Report Number: 0009617840-2016-00046
Event Type: Malfunction
Date Received: December 19, 2016
Date of Event: November 29, 2016
Report Date: April 28, 2017
Manufacturer: ZIMMER CAS
Product Code: OLO
PMA / PMN Number: PK141601
Removal / Correction Number: ZFA 2017-23
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE PART CONFIRMS THAT ONE OF THE SPIKES HAS COMPLETELY DISASSEMBLE FROM THE VALIDATION TOOL BASE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE IMPACTION FORCE TRANSMITTED IN THE DRIVE PIN HEAD DURING THE INSTALLATION OF THE VALIDATION TOOL. THIS DEVICE IS PART OF A RECALL PREVIOUSLY INITIATED TO ADDRESS THE REPORTED ISSUE. 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.

Additional Manufacturer Narrative · 1

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

Description of Event or Problem · 1

DURING A RIGHT KNEE ARTHROPLASTY, THE PIN SEPARATED FROM THE BODY OF THE VALIDATION TOOL. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
837330	VALIDATION TOOL	ORTHOPEDIC STEREOTAXIC INSTRUMENT	OLO	ZIMMER CAS	N/A	140860

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR