MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The customer has indicated the device will be returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

Item returned to hospital with information that the motor works intermittently or stalls.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed final report, as the investigation is complete.The following sections were updated/corrected: date of report, description of event or problem, device identification, premarket identification, type of report, follow up type, device evaluated by mfr, device manufacture date, adverse event problem, usage of device, additional mfr narrative.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Technical review and physical evaluation: on (b)(6), 2019 the item returned to hospital with information that the motor works intermittently or stalls.During evaluation of the device the reported event was confirmed.The motor and needle bearing were defective.The unit was out of calibration.The control bar position was not correct and some screws were found to be non conforming.Furthermore, inspection of the power supply subcomponent did not confirm the reported event but the earth point was missing from the unit.The customer, within the customer feedback report, was informed that the product was not repaired as it was technically unrepairable thus not meeting the quality requirements set by medical devices regulations and it is therefore not compliant for use.The power supply was returned unrepaired.The technician then replaced the defective components, recalibrated the device and verified that it was functioning as intended.The device was then returned to the customer without further incident.Probable/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the motor worked intermittently.Repair included replacement of the motor and other defective components.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: based on the information provided, this investigation determined that there is no need for further action at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.

Event Description

It was reported that the sales rep managed to get in touch with the staff at the hospital and was told that the device was malfunctioning after the sterilization.It has not been used at surgery due to this reason.We have no information what other device was used instead.There was no delay, no impact to patient, no contributing conditions.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9089166
• MDR Text Key: 159330462
• Report Number: 0001526350-2019-00798
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 32928300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1