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

Catalog Number 89-8507-400-00

Device Problems Defective Device (2588); Ambient Noise Problem (2877); Appropriate Term/Code Not Available (3191)

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

Event Date 04/12/2021

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.Additional information regarding serial number of the device is unknown at the time of this report.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number unknown, got stopped when initiating to cut and when device got in contact with the bone.A delay of 35 minutes in the surgery procedure was reported.The reason for the delay was the time needed to go to another hospital to get another handpiece 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.Follow up attempts were performed to contact the customer, in order to obtain the serial number of the product.However, no feedback on serial number was provided at the time of this report.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece, part number: 89-8507-400-00, serial number: (b)(6), got stopped when initiating to cut and when device got in contact with the bone.A delay of 35 minutes in the surgery procedure was reported.The reason for the delay was the time needed to go to another hospital to get another handpiece 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).Additional information was received regarding the serial number of the device.The serial number of the device is 462213.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.

Manufacturer Narrative

Zimmer biomet complaint (b)(4) universal modular electric/battery double trigger handpiece part number 89-8507-400-00, serial number (b)(6), was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor was noisy and the controller board wires were damaged.The event reported by the customer was not confirmed.As of repair, motor was replaced with the potted wired controller.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 double trigger handpiece, part number 89-8507-400-00, serial number (b)(6), got stopped when initiating to cut and when device got in contact with the bone.A delay of 35 minutes in the surgery procedure was reported.The reason for the delay was the time needed to go to another hospital to get another handpiece 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 DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 11734988
• MDR Text Key: 262868734
• Report Number: 0008031000-2021-00006
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5011513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other