MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 7X25MM ROUND HD; PLATE, FIXATION

Catalog Number 905613

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).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.

Event Description

T was reported during surgery on the left knee ligament, the screw has broken and could not be entirely removed from the patient knee.A part was unlocatable and remained implanted.The surgery was completed by replacing the screw by another one.

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.Operative notes were provided.However, the alleged breakage of the screw was not specifically outlined within the operative records.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

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: GENTLE THREAD 7X25MM ROUND HD
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10374822
• MDR Text Key: 201944989
• Report Number: 0001825034-2020-03095
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K982497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

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 Expiration Date: 10/27/2023
• Device Catalogue Number: 905613
• Device Lot Number: 925680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/31/2020; 11/06/2020
• Supplement Dates FDA Received: 09/24/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 112