MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SUPER MAXCUTTER

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the instrument did not cut and was locked.No further information is available at this time.

Event Description

No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device shows wear from use.The trigger mechanism is stuck and cannot be pressed in or pulled out of position.The complaint is confirmed.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the surgeon could not use the instrument during surgery as it would not move.The surgery was completed with another instrument without impact to the patient.No further information is available at this time.

• Brand Name: SUPER MAXCUTTER
• Type of Device: CUTTER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9109226
• MDR Text Key: 160058369
• Report Number: 0001825034-2019-04259
• Device Sequence Number: 1
• Product Code: HXZ
• 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,Followup
• Report Date: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 900342
• Device Lot Number: 100420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 12/18/2019
• Supplement Dates FDA Received: 10/01/2019; 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1