FDA Adverse Event Malfunction Summary report: N

NATURAL-HIP SYSTEM FULLY-TOOTHED BROACH

MDR report key: 2080192 · Received April 7, 2011

Report

Report Number: 1822565-2011-00885
Event Type: Malfunction
Date Received: April 7, 2011
Date of Event: March 7, 2011
Report Date: March 11, 2011
Manufacturer: ZIMMER, INC.
Product Code: HAW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: A PORTION OF THE POST ON THE RETURNED DEVICE HAS FRACTURED OFF. THE DEVICE HAD A POTENTIAL FIELD AGE OF 9 YEARS AND 5 MONTHS. THE TEETH OF THE BROACH EXHIBIT DAMAGE, WHICH INDICATES EXTENSIVE USE OVER THE YEARS OF ITS TIME IN SERVICE. SURGICAL NOTES WERE NOT PROVIDED. BONE QUALITY IS UNKNOWN. THE DETAILS OF HOW IT WAS BEING USED AND IN CONJUNCTION WITH WHICH INSTRUMENTS ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE RETURNED DEVICE MEETS PRINT SPECIFICATION WHERE MEASURED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE BROACH HANDLE ENGAGEMENT TIP BROKE DURING SURGERY, DURING BROACHING. THE ITEM WAS REMOVED USING EXTRACTOR INSTRUMENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NATURAL-HIP SYSTEM FULLY-TOOTHED BROACH	HIP INSTRUMENT	HAW	ZIMMER, INC.		1506659

Patients

Seq	Age	Sex	Outcome	Treatment
1