MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE

Catalog Number 912082

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the clear sleeve of the device would not slide freely like normal during a procedure.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 visual examination of the returned product identified the product was not cycled.While function testing the device, the clear sleeve was fractured.As such it could not be determined if the device was conforming.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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 is available at the time of this report.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE
• 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: 15797232
• MDR Text Key: 303733206
• Report Number: 0001825034-2022-02589
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418(17)270413(10)033120
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 033120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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