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

Model Number N/A

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Information (3190)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Report source: event 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 device did not successfully deploy upon insertion.No significant delay to surgery or adverse consequence to the patient.No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Visual examination of the returned product identified the suture was returned separated from the handle.The sheath on the handle was pushed all of the way back out of place.Dimensional analysis was done one the tip and was found in conformance.The complaint is unable to be confirmed.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.

Event Description

No further information available at the time of this reporting.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8925492
• MDR Text Key: 203173878
• Report Number: 0001825034-2019-03585
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 038290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 18 YR