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

Catalog Number 00882100100

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problems Suture Abrasion (2497); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device took too large of a graft.The event timing was during surgery, and it is unknown whether it caused any harm or injury.No further information has been provided.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).D4: udi#: (b)(4).The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.The customer also returned a power supply, serial number (b)(6), for evaluation.Product review of the electric dermatome on october 1, 2019 revealed that the control bar was below the correct position.The motor speed was below specifications and the spring seal needed replaced.The calibration was out of specifications at all settings.Product review of the electric dermatome power supply on september 27, 2019 revealed that the power switch was broken.Repair of the electric dermatome was performed by zimmer biomet surgical on october 1, 2019 which included replacement of the needle bearing, bearings, and spring seal.The control bar position was corrected and the unit was recalibrated.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Repair of the electric dermatome power supply was performed by zimmer biomet surgical on september 27, 2019 which included replacement of the power switch.Electric dermatome power supply, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the electric dermatome had a low control bar that could cause it to cut too deeply, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the needle bearing, bearings, and spring seal were replaced and the control bar position was corrected and the unit was recalibrated.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

The surgeon had to place suture to fix the defect.No further event information is available.

• 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: 9146847
• MDR Text Key: 161772672
• Report Number: 0001526350-2019-00847
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 63574779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention