MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the sternal closure band pulled out through part of the manubrium while reducing the sternal halves following a median sternotomy.The patient was closed with a new set of sternal bands and plates.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint cannot be verified.The device was not returned for investigation, as it was reported that the system was discarded following this event.No photos, scans, or physician's reports were provided.The dhr for this product was reviewed, no non-conformances were found.There are no indications of manufacturing defects.For this system (74-0004) and the previous one year (from the notification date) regarding the system tearing through the sternum, there is a complaint rate of 0.02%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined.It is possible that the patient had poor bone quality to achieve the proper tension with this device or that user applied too much tension.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.

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9934453
• Report Number: 0001032347-2020-00200
• Device Sequence Number: 13625725
• Product Code: HRS
• UDI-Device Identifier: 00841036190668
• UDI-Public: 00841036190668
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 065880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR