MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE 5 DEGREES LEFT MEDIAL/RIGHT LATERAL; INSTRUMENT, KNEE

Model Number N/A

Device Problem 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: switzerland.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: 00590102000 headless trocar drill pin 3.2 mm dia75 mm length, lot# unk, mdr: 0001822565-2022-02846.

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.

Manufacturer Narrative

(b)(4). this follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10   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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

Event Description

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

• Brand Name: TIBIAL CUT GUIDE 5 DEGREES LEFT MEDIAL/RIGHT LATERAL
• 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: 15511987
• MDR Text Key: 306269842
• Report Number: 0001822565-2022-02845
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024582842
• UDI-Public: (01)00889024582842(10)64803698
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K200151
• 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: 42539905195
• Device Lot Number: 64803698
• 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
• Date Device Manufactured: 06/26/2020
• 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