MAUDE Adverse Event Report: ZIMMER SURGICAL SA OSCILLATING SAW ATTACHMENT

Catalog Number 89-8509-450-60

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Information (3190)

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 report will be submitted if new information is received and/or after the investigation of the product.

Event Description

It was reported that the oscillating saw attachment part number 89-8509-450-60, serial number (b)(4) was connected to the universal modular electric/ battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4), when it stopped working in the middle of the case.Therefore, the two products were recorded under complaint and a report will 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 4in1 cutting guide.Batteries was 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 second report relative to the universal modular electric/ battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) is the: 0008031000-2019-00019.

Event Description

It was reported that the oscillating saw attachment part number 89-8509-450-60 serial number (b)(4) was connected to the universal modular electric/ battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4), when it stopped working in the middle of the case.Therefore, the two products were recorded under complaints and a report will 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 4in1 cutting guide.Batteries was 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 disapointed 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 second initial report relative to the universal modular electric/ battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) is the: 0008031000 - 2019 - 00019.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A second follow-up report will be sumitted if new information is received or product is received.

• Brand Name: OSCILLATING SAW ATTACHMENT
• Type of Device: OSCILLATING SAW ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 8883726
• MDR Text Key: 153986323
• Report Number: 0008031000-2019-00018
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8509-450-60
• Device Lot Number: 5007281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR