MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISPOSABLE NITINOL PUSHER; SUTURE PUNCH

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : not returned to manufacturer.

Event Description

It was reported the suture would not deploy with use of the suture passer.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: DISPOSABLE NITINOL PUSHER
• Type of Device: SUTURE PUNCH
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7544295
• MDR Text Key: 109251370
• Report Number: 0001825034-2018-03148
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 902092
• Device Lot Number: 248420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 902099 SUTURE PASSER. LOT 494420; 902099 SUTURE PASSER. LOT 494420