MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE

Catalog Number 89-8507-400-10

Device Problems Mechanical Problem (1384); Defective Device (2588); Appropriate Term/Code Not Available (3191)

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

Event Date 05/09/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(4), got stopped while reaming the im canal during a cmn case.A delay of 40 minutes in the surgery procedure was reported.The reason for the delay was that the hospital back up drill was unsterile, therefore had to be sterilized in order to complete the surgery.The patient was under anesthesia during this delay.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number 437942, got stopped while reaming the im canal during a cmn case.A delay of 40 minutes in the surgery procedure was reported.The reason for the delay was that the hospital back up drill was unsterile, therefore had to be sterilized in order to complete the surgery.The patient was under anesthesia during this delay.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal modular electric/battery singletrigger handpiece, part number 89-8507-400-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal modular electric/battery singletrigger handpiece, part number 89-8507-400-10, serial number (b)(6) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor was seized, the controller board wires as well as the battery support were damaged and the trigger was loose.The event reported by the customer was confirmed.As of repair, motor and the front face (including trigger) was replaced with the potted wired controller and the battery support.After repair, the device passed final tests and it was returned to the customer.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6), got stopped while reaming the im canal during a cmn case.A delay of 40 minutes in the surgery procedure was reported.The reason for the delay was that the hospital back up drill was unsterile, therefore had to be sterilized in order to complete the surgery.The patient was under anesthesia during this delay.There was no additional harm or injury to patient/operator reported.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 11854594
• MDR Text Key: 251706645
• Report Number: 0008031000-2021-00008
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-10
• Device Lot Number: 5008971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1