MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-UNKNOWN-DRILL; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the offset reamer handles tip broke during reaming the phase of the surgery.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; h6.Proposed component code: mechanical (g04)-drill.Visual examination of the provided pictures identified the reamer fractured and is missing two of the sharp edges of the device.The device is covered in bio-debris.No further evaluation can be made from the provided pictures.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: HIP-UNKNOWN-DRILL
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17670122
• MDR Text Key: 322493013
• Report Number: 0001822565-2023-02361
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: HIP-UNKNOWN-DRILL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1