MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 3.5 LOCKING SCREW; PLATE, FIXATION, BONE

Catalog Number UNK 3.5 LOCKING SCREW

Device Problems Fracture (1260); Migration (4003)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00796 0001822565-2024-00797 0001822565-2024-00798 0001822565-2024-00799 d10: item# unk 3.5 locking screw; lot# unknown item# unk 3.5 locking screw; lot# unknown item# unk 3.5 locking screw; lot# unknown item# unk cerclage wire; lot# unknown 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 that the patient was experiencing pain approximately one (1) year post-implantation.Subsequently, an x-ray was taken to show the patient's 3.5 locking screws backed out from inside the plate's screw holes.As a result, the patient was revised one (1) month later, where 4 screws were explanted and one was noted to have fractured.X-rays were received by zimmer biomet and were reviewed by a radiologist, where it was also noted that the proximal cerclage cable was disrupted.Attempts have been made and no further information has been provided.

• Brand Name: UNK 3.5 LOCKING SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18873885
• MDR Text Key: 337305936
• Report Number: 0001822565-2024-00795
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK 3.5 LOCKING SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 79 KG