MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN STERNALOCK SCREW; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Impaired Healing (2378)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00085.Medical products: sternalock 360 multi-implant system, part# 74-0004, lot# 066030.

Event Description

It was reported the patient underwent a revision to remove sternal closure device six (6) months following implantation due to infection.It was suggested that the patient condition of diabetes may have contributed to the delayed healing of an infection.It was indicated the 8 hole x plate component had been implanted on the manubrium instead of the body of the sternum as recommended in the ifu.Attempts have been made and no further information is available.

Manufacturer Narrative

Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device and therefore not reportable.The patient developed an infection and product was explanted approximately 5 1/2 months after implant.It was noted the patient had diabetes which is known to impact a patient's ability to heal and may contribute to development of an infection.During the investigation process a review of the sterile certifications were not reviewed for the unknown sternalock screw, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As all product manufactured follow appropriate standards, and the reported infection occurred > 90 days, devices can be excluded as a possible source.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities such as risk factors.In this case, information received indicates the patient has diabetes which is a known risk factor which can lead to slow or impaired healing, and predisposition to infection.

Event Description

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

• Brand Name: UNKNOWN STERNALOCK SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11368709
• MDR Text Key: 241409970
• Report Number: 0001032347-2021-00086
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 86