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

Catalog Number 00880100200

Device Problem Expulsion (2933)

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

Event Date 05/21/2019

Event Type  malfunction  

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 the dermatome tube has exploded intraoperatively.No patient harm/consequences.There was no delay.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

(b)(4).The device history record (dhr) for the dermatome hose, part number 00880100200 and serial number (b)(6), review by de-soutter medical limited noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from kantonsspital graubünden that a dermatome hose exploded intraoperatively.On (b)(6)2019, a returned product investigation was performed on the dermatome hose.The physical evaluation revealed that the inner hose had blown apart at the connector.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the dermatome hose came apart at the connector, 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 investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: DERMATOME HOSE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8692364
• MDR Text Key: 147782298
• Report Number: 0001526350-2019-00471
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 18 YR