MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 9X25MM ROUND HD; FASTENER, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060)

Event Date 01/03/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat: 905608 lot: 490880 gentle thread 9x30mm round hd.Report source: foreign- france.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00064.

Event Description

It was reported patient underwent an anterior fibrosis resection three months post implantation due to cyclops syndrome.No additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h3, h4, h6, h10 cyclop syndrome is caused by a scar tissue nodule adjacent to the tibial tunnel of the anterior cruciate ligament graft after surgery.As the scar tissue builds around the graft and zimmer biomet's implants were directly correlated with the screws, there are no allegations against the device and all implants remain in place.Hence, the reported device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

No additional event information is available at the time of this report.

• Brand Name: GENTLE THREAD 9X25MM ROUND HD
• Type of Device: FASTENER, 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: 16138619
• MDR Text Key: 307098455
• Report Number: 0001825034-2023-00065
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00880304006669
• UDI-Public: (01)00880304006669
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 905617
• Device Lot Number: 510340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2008
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR