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

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Event occurred in (b)(6).

Event Description

It was reported that during a procedure, the instrument jammed while the surgeon was attempting to cut the suture and was unable to cut.A second instrument was able to be used successfully.There was no impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The returned product was visually inspected, and it was noted that a lot of the blue anodize was worn off of the instrument.The trigger binds and gets stiff when working the trigger and does not advance the punch all the way.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: SUPER MAXCUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8203010
• MDR Text Key: 131766699
• Report Number: 0001825034-2018-11542
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

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: 309580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 04/01/2019
• Supplement Dates FDA Received: 01/08/2019; 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1