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

Model Number N/A

Device Problems Material Deformation (2976); Noise, Audible (3273); Patient Device Interaction Problem (4001); Explosion (4006)

Patient Problem Abrasion (1689)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during surgery, the dermatome tube broke and exploded with a very important noise.Surgeon was very surprised by the sudden important noise.There was a loss of skin that was removed and had to use another dermatome to take an additional skin graft to finish the surgery.A delay to surgery of 5 minutes.Everyone in the room had a feeling of a wheezing ear for the remaining time of the procedure and afterwards.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual examination of the returned product/provided pictures identified the hose was damaged and split open near the handpiece connector.Lot/serial identification is necessary for review of device history records, and lot/serial identification was not provided.Device is used for treatment.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

No additional event information.

• Brand Name: DERMATOME HOSE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10451734
• MDR Text Key: 204327319
• Report Number: 0001526350-2020-00715
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 00880100200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR