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

Catalog Number 89-8507-400-00

Event Date 07/23/2019

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 double trigger handpiece part number 89-8507-400-00, serial number: (b)(4) was connected to oscillating saw attachment, part number 89-8509-450-60 serial number 420284 when it stopped working in the middle of the case.It worked when testing outside patient but stopped when applying it to the patient through the for in one cutting guide.Therefore, the two products were recorded under complaint and a report was be done for each product.In the event reported by the customer, it was reported that during a tka case, when cutting the last anterior shamfer, the handpiece connected to oscillating saw was able to work when it was tested outside the patient but stopped when applying it to the patient through the 4 in 1 cutting guide.Batteries were changed and the fault/ re-boot options were used.The surgery was completed with sagittal recip saw to finish the last bone cut.The case ended well and was acceptable.A delay of 45 minutes was reported.The reason of this delay was due the problem with a device and product change.The patient was under anesthesia at the time of the delay.Surgeons were disappointed due to faulty saw system as it was not the first case and it was extending theatre time with an open wound and increased the risk of infection.There was no additional harm or injury to the patient reported.The report relative to the oscillating saw attachment, part number 89-8509-450-60, serial number (b)(4) is the: 0008031000 - 2019 - 00018.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(6), was connected to oscillating saw attachment, part number 89-8509-450-60 serial number (b)(6) when it stopped working in the middle of the case.It worked when testing outside patient but stopped when applying it to the patient through the for in one cutting guide.Therefore, the two products were recorded under complaint and a report was be done for each product.In the event reported by the customer, it was reported that during a tka case, when cutting the last anterior shamfer,the handpiece connected to oscillating saw was able to work when it was tested outside the patient but stopped when applying it to the patient through the 4 in1 cutting guide.Batteries were changed and the fault/ re-boot options were used.The surgery was completed with sagital recip saw to finish the last bone cut.The case ended well and was acceptable.A delay of 45 minutes was reported.The reason of this delay was due the problem with a device and product change.The patient was under anesthesia at the time of the delay.Surgeons were disappointed due to faulty saw system as it was not the first case and it was extending theatre time with an open wound and increased the risk of infection.There was no additional harm or injury to the patient reported.The initial report relative to the oscillating saw attachment, part number 89-8509-450-60 serial number (b)(6) is the: 0008031000 - 2019 - 00018.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A second report will be sent if additional information is received or if the device is returned to the manufacturer.H3 other text : not returned.

• 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, chemin du pre fleuri; plan les ouates CH-12 28; SZ CH-1228
• MDR Report Key: 8883537
• MDR Text Key: 153974259
• Report Number: 0008031000-2019-00019
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device 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: 89-8507-400-00
• Device Lot Number: 5007181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No