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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem Laceration(s) (1946)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery, the unit's power was not strong enough.No additional skin graft needed but wound was created due to the malfunction, so a dressing was applied.The same device was used with an alternative nitrogen source that could increase high enough for the dermatome to operate.A delay of about 15 minutes was reported.

Event Description

No additional event information available.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).D4 - udi# - (b)(4).Reported issue: on june 14, 2019, it was reported that the unit power was not strong.Same device was used with an alternative nitrogen source that could increase high enough for the dermatome to operate.The customer returned an air dermatome device, serial number (b)(6), for evaluation.The customer also returned a hose and 1/2/3/4 inch width plates, for evaluation.Dhr review: 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.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(6) as documented in the repair reports in livelink.Device evaluations results/investigation findings: product review of the air dermatome on july 17, 2019 revealed that the calibration was out of specifications at the zero setting only.The motor speed was within specifications and the control bar was in the correct position.Repair of the air dermatome was performed by zimmer biomet surgical on july 17, 2019 which included replacement of the throttle hinge gasket, fine adjustment cam, motor sleeve, motor, planetary carrier, bearings, internal retaining ring, spring seal, vespel bearings, and semi-circle bearings.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the device to become out of calibration.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8764348
• MDR Text Key: 150140164
• Report Number: 0001526350-2019-00535
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 63415160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other