MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 105MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00014 delano lag screw item #: 814510105 lot #: ug1111305d delano a/r screw item #: 814501090 lot #: dnccm1 foreign - event occurred in (b)(6).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.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

It was reported patient underwent revision approximately four (4) months ago post implantation due to non-union of the fracture and fracturing of the nail and lag screw.It was reported approximately three (3) weeks ago patient underwent revision.During procedure, components were removed and replaced.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.No alleged problem or complaint was made against this device.Reporter stated they were just providing all the implanted devices.No problem was found with the returned device, and no findings against the lag screw was noted in the x-ray.The initial report was forwarded in error and should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: HFN LAG SCREW 10.5MM X 105MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11125266
• MDR Text Key: 225342787
• Report Number: 0001825034-2021-00015
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 814510105
• Device Lot Number: UG1111305D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10; SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention