FDA Adverse Event Malfunction Summary report: N

HGP II

MDR report key: 5685643 · Received May 27, 2016

Report

Report Number: 0001822565-2016-01782
Event Type: Malfunction
Date Received: May 27, 2016
Date of Event: October 6, 2015
Report Date: October 8, 2015
Manufacturer: ZIMMER, INC.
Product Code: HTW
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ME, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

RETROSPECTIVE REPORT FORM CODE: (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED HGP II CUP FLEXIBLE DRILL, CONFIRMED A BENT/UNRAVELED STAINLESS STEEL FLEXIBLE SHAFT. DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THIS IS A PREVIOUSLY INVESTIGATED DESIGN ISSUE. THIS DEVICE WAS USED FOR TREATMENT. THE FAILURE MODE OF BENT/UNRAVELED STAINLESS STEEL FLEXIBLE SHAFTS, OF HGP II CUPS FLEXIBLE DRILLS HAS BEEN PREVIOUSLY INVESTIGATED AND HAS BEEN ADDRESSED BY A DESIGN CHANGE. BASED ON THE MANUFACTURE DATE, THE RETURNED DEVICE HAS A POTENTIAL FIELD AGE OF 1 YEAR AND 2 MONTHS. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE PART-LOT COMBINATION ASSOCIATED WITH THE REPORTED DEVICE. THIS REPORT, ALONG WITH THE ADDITIONAL ATTACHED SUMMARIZED EVENTS FOR A TOTAL OF 168 EVENTS ARE BEING REPORTED UNDER EXEMPTION NUMBER E2016007. THESE MDRS WERE IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE ARE BEING FILED RETROSPECTIVELY.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE LONG FLEXIBLE DRILL BIT WAS BEING USED FOR PLACEMENT OF AN ACETABULAR SCREW. THE FLEXIBLE SHAFT STARTED TO UNCOIL AND BREAK. THERE WAS A 3 MINUTE DELAY IN SURGERY AND SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340320	HGP II	HGP II CUP FLEX DRILL	HTW	ZIMMER, INC.	N/A	62778437

Patients

Seq	Age	Sex	Outcome	Treatment
1