MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KIT; INSTRUMENT, TRAUMA

Catalog Number UNKNOWN KIT

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 approximately three (3) weeks ago during an ankle replacement surgery, the instrument and implant kit provided was incomplete.The procedure was unable to be completed and the patient was awakened.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2 upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.There was no problem found with the reported device.This reported event was an aborted procedure after induction of anesthesia due to missing components of a kit that was put together by the hospital, not sold by zb.It was further found that the courier did not deliver the product on time.As a part of the safe surgery checklist by the world health organization, it is the responsibility of the surgical team to ensure that all implants and equipment are to be confirmed and inspected as ready for use prior to procedure start.There is no indication of patient injury or harm sustained while under anesthesia or as a result of this occurrence.If any further information which would change or alter any conclusions or information, a supplemental report 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: UNKNOWN KIT
• Type of Device: INSTRUMENT, TRAUMA
• 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: 12869911
• MDR Text Key: 281268076
• Report Number: 0001825034-2021-03200
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NI
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN KIT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/26/2022
• 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: Unknown
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose