MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM

Catalog Number 89-8509-451-41

Device Problem Unintended Ejection (1234)

Patient Problem Eye Injury (1845)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal wire driver, micrometric, 1-4mm, part number 89-8509-451-41, serial number (b)(4), was returned for complaint investigation on the 4th of august 2021.Visual and functional tests were performed.Upon receipt, it was confirmed that the locking system that holds the wire (passive hold) had an issue.As of repair, the locking system was replaced.After repair, the device passed final tests and it was returned to the customer.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.

Event Description

It was reported by a chief nurse, that when the locking lever was released of the universal wire driver, micrometric, 1-4mm, part number 89-8509-451-41, serial number (b)(4) , the wire was shot out and the operating assistant was wounded in the right eyeball as it penetrated the assistant's eye.The assistant underwent the surgery to have the wire removed and a treatment to have her eye cornea stitched together.The operating assistant is still undergoing medical treatment and did not recover.This event happened during surgery with no delay reported.Further information regarding the recovery of the injured operating assistant will not be provided due to personal data protection.This new information was reported 2.5 months after the initial event ("the wire shot out"): the product was already investigated and returned to the customer at this time.

• Brand Name: UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM
• Type of Device: UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12672326
• MDR Text Key: 277663956
• Report Number: 0008031000-2021-00037
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8509-451-41
• Device Lot Number: 5011431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1