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

Catalog Number 00880100100

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

Repair request was reported because the screws that maintain the plates are missing.Event timing was before surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Result code- screws missing from the dermatome.The device history record for zimmer air dermatome serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(4) prior to (b)(6) 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported from (b)(6) that a dermatome was missing a width plate screw.The customer returned a zimmer air dermatome serial number (b)(4) for evaluation.Evaluation of the device on 13 march 2019 found that the device was out of calibration at the zero setting and that the width plate screws were missing.Repair of the device occurred on 30 april 2019 and involved replacing the missing screws and the needle bearing as well as recalibrating the device.The technician then tested and verified that the dermatome was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the width plate screws were missing from the device, it cannot be determined from the information provided as to what caused the screws to go missing.Therefore, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• Brand Name: ZMR AIR DERMATOME HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8379743
• MDR Text Key: 137462599
• Report Number: 0001526350-2019-00143
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 33163800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1