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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL SA UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM Back to Search Results
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.
 
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Brand NameUNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM
Type of DeviceUNIVERSAL 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 Key12672326
MDR Text Key277663956
Report Number0008031000-2021-00037
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89-8509-451-41
Device Lot Number5011431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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