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

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2019 - 02079.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.

Event Description

It was reported the anchor did not deploy as the sleeve felt sticky and therefore could not be fully seated.No further information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi : (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.

Event Description

No further information available at the time of this reporting.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTNER, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8635999
• MDR Text Key: 145931873
• Report Number: 0001825034-2019-02078
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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 Expiration Date: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 303300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 912076 JGRKNT 1.0MM MINI 2-0NDLS LOT 763540; 912076 JGRKNT 1.0MM MINI 2-0 NDLS, LOT 763540
• Patient Age: 20 YR