MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM DRIVER; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip arthroplasty, the stem inserter fractured.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified blue handle has fractured around the circumference of the handle at the locking pin.Strike plate shows indentations from previous uses.Nicks, gouges, and scratches were noted to the device.One of two screws that are in the chuck sleeve was missing upon return.Nicks, gouges, and scratches were noted to the device.Device has an approximate field age of approximately 17 years.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause unchanged.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

There is no update to the prior event description provided.

• Brand Name: STEM DRIVER
• Type of Device: INSTRUMENT, HIP
• 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: 12435322
• MDR Text Key: 270315081
• Report Number: 0001822565-2021-02511
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00771205700
• Device Lot Number: 60842576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 02/20/2023; 05/15/2023
• Supplement Dates FDA Received: 03/14/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1