MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIA 75 MM LENGTH; INSTRUMENT, KNEE

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs 42539905195 tibial cut guide 5 degrees left medial/right lateral lot# 64803698 mdr: 0001822565-2022-02845.

Event Description

The warehouse received a cutting block with a pin stuck in a hole.The pin is broken.Items were in a loaner set.No additional information.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified the guide showed signs of repeated use.A trocar pin has been seized into one of the guide's holes.The tip of the trocar pin has been fractured off and was not returned.Dimensional analysis of the trocar pin determined that the product, where measured, was conforming to print specifications.Lot identification is necessary for review of device history records, lot identification was not provided.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: HEADLESS TROCAR DRILL PIN 3.2 MM DIA 75 MM LENGTH
• Type of Device: INSTRUMENT, KNEE
• 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: 15511992
• MDR Text Key: 301120579
• Report Number: 0001822565-2022-02846
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 00590102000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10 NARRATIVE