MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; FASTENER, FIXATION

Catalog Number 912082

Device Problems Fracture (1260); Material Twisted/Bent (2981); Mechanical Jam (2983)

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

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (01) 00880304523418 (17) 241031 (10) 672480, (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, the clear sleeve of the juggerknot did not move smoothly.Further, it was identified that tip of the inserter was bent and fractured.No fractured pieces retained in the patient's body.There was surgical delay of 15 minutes as a result of this malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9915546
• MDR Text Key: 186118057
• Report Number: 0001825034-2020-01368
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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 Catalogue Number: 912082
• Device Lot Number: 672480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1