MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTNER, FIXATION

Model Number 110024773

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2023

Event Type  Injury  

Event Description

During a right knee acl reconstruction with bilateral meniscus repair, it was reported that a functional issue occurred with the juggerstitch device.When trying to deploy the first anchor, it did not come out of the device.When trying to deploy the second anchor, both came out of the device.Upon pulling the device out, the juggerstitch needle was bent.The anchors remained in the meniscus, and the procedure was completed without injury or untoward outcomes.Another juggerstitch was used to complete the procedure.There was a 34 minute delay.No further information is available.

Manufacturer Narrative

(b)(4).G2: foreign: india.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g1-2, g3, g7, h1, h2, h6, h10 visual examination of the returned product identified no etch on the device and there was no packaging returned.There were no sutures or anchors returned with this device.The device has been cycled 2 times and the tip of the device is bent and creased.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTNER, FIXATION
• 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: 16808896
• MDR Text Key: 313941310
• Report Number: 0001825034-2023-00900
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304690073
• UDI-Public: (01)00880304690073(17)270504(10)157440
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110024773
• Device Catalogue Number: 110024773
• Device Lot Number: 157440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 08/18/2023; 01/22/2024
• Supplement Dates FDA Received: 08/23/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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 Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Male