MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; SCREW, FIXATION, INTRAOSSEOUS/SPORTS MEDICINE

Model Number 912076

Device Problems Fracture (1260); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while the surgeon was attempting to implant the implant, the anchor pulled out.Upon receipt of product returning, it was determined that the tip of the inserter was fractured.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tip of the nitinol pusher has been fractured off.The piece that was fractured was not returned.Suture and needle do appear to be intact.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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 event information available at the time of this report.

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS/SPORTS MEDICINE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16132043
• MDR Text Key: 308638000
• Report Number: 0001825034-2023-00057
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)00880304520820(17)270811(10)0002458735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 912076
• Device Catalogue Number: 912076
• Device Lot Number: 0002458735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 115 KG