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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).During the investigation, unknown screws were identified as a reportable device in the event.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the plate.Part and lot identification are necessary for review of device history records, neither were provided for the screws.A definitive root cause cannot be determined.It was reported: the doctor in charge speculated that it was probably because the sternum was not cut correctly in the middle.However, without medical records a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00587.Medical products: sternalock blu system plate, 8 hole x, part# 73-2623, lot# ni.Report source foreign: (b)(6).

Event Description

It was reported the patient underwent a sternum dissection after the sternal closure plate came off post-operatively.The surgeon speculated that the sternum was not cut correctly in the middle during the original surgery.Following the revision, the patient recovered and was transferred to another hospital.No additional patient consequences have been reported.

• Brand Name: UNKNOWN STERNALOCK SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11939222
• MDR Text Key: 254494480
• Report Number: 0001032347-2021-00334
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention