MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME II HOSE: SYNTHES (AO), 3 M; PNEUMATIC SURGICAL POWER TOOL SYSTEM HOSE

Catalog Number 00885100203

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during the kit inspection at the zimmer biomet france site, the operator detected that air is leaking from the end of the hose.There was no patient involvement or adverse events as a result of the incident.

Event Description

No additional information.

Manufacturer Narrative

This follow up report is being submitted to report additional information the device history record (dhr) for the zimmer air dermatome ii hose: synthes (ao), 3 m, part number 00885100203 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.Using view 09-23 from the etq reliance system, there were 22 complaints that contains the part number and keyword search using the character string leaking based on the reported event.Using view 09-23 from the etq reliance system, a review was completed using the search criteria of the part number and open and closed complaints using the character string leaking sorted by manufacturing date.The review resulted as 14 being the highest occurrence.Using view 09-23 from the etq reliance system, there were 23 complaints that shared the same part number and lot number, n/a, based on the reported event.Note: complaint history was performed on all dermatome hose item numbers (00885100202, 00885100203, 00885100204, 00885100205, 00885100206, 00885100207, 00880100200).As the lot number is unknown for this event, no further evaluation is required.On 25 jun 2019, it was reported that a zimmer air dermatome ii hose: synthes (ao), 3 m was leaking air from the hose.On 26 aug 2019, a returned product investigation was performed on the zimmer air dermatome ii hose: synthes (ao), 3 m.The physical evaluation revealed that the o-ring that seals the airflow from the hose was mis-seated which allowed for air to leak from the hose.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the zimmer air dermatome ii hose: synthes (ao), 3 m had a mis-seated o-ring causing an air leak, 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: ZIMMER AIR DERMATOME II HOSE: SYNTHES (AO), 3 M
• Type of Device: PNEUMATIC SURGICAL POWER TOOL SYSTEM HOSE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8798193
• MDR Text Key: 151301510
• Report Number: 0001526350-2019-00558
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00885100203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1