MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC INSERTER; INSTRUMENT, MANUAL

Model Number N/A

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2014

Event Type  malfunction  

Manufacturer Narrative

The product was returned and the event was confirmed.Investigation found the instrument has been in the field for 9 years and shows extensive wear from use.The leading screw threads are damaged and worn down which probably prevented the inserter from capturing the trial screws threads.Instrument was simply worn beyond it's useful life.Review of dhr and complaint history were performed and no deviations or trends were noted.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under care and handling of instruments, number 1 states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.Care must be taken to avoid compromising their exacting performance." following review, no new risks were identified.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.

Event Description

It was reported that during a total primary hip fracture repair procedure on (b)(6) 2014, the surgeon attempted to engage the threaded ringloc rod with the hole in the trial magnum cup and was unsuccessful.The surgeon then attempted to use a taperloc stem handle to engage the trial magnum cup and was successful.Once engaged, the surgeon manually adjusted the rod.There was no delay in the procedure.No adverse events have been reported as a result of the malfunction.

• Brand Name: RINGLOC INSERTER
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6915235
• MDR Text Key: 88216338
• Report Number: 0001825034-2017-07833
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-434540
• Device Lot Number: 941540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 49 YR