MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 8 HOLE X; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

(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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: unknown sternalock screws, lot ni.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.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- 2021-00337.

Event Description

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

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE X
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10895815
• MDR Text Key: 217998622
• Report Number: 0001032347-2020-00588
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036141028
• UDI-Public: 00841036141028
• Combination Product (y/n): N
• PMA/PMN Number: K011076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 73-2623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization