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

Model Number UNKNNOWN

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

Patient Problem Death (1802)

Event Date 09/04/2019

Event Type  Death  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as the customer has not responded to the product return request; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Occupation: sales representative.

Event Description

It was reported a patient died due to a screw puncturing the right ventricle.The patient was implanted with a sternal closure device that included an unknown quantity of plates and screws.The patient experienced cardiopulmonary arrest and received chest compressions.The chest compressions resulted in one of the sternal closure screws puncturing the right ventricle resulting in death.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following fields were updated: b4 date of this report b5 describe event or problem e1 initial reporter name e2 health professional e3 occupation g3 report source g4 date received by manufacturer g7 type of report h2 follow up type h10 additional narratives/data.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11 ¿ medical products: sternalock blu system plate, 8 hole x , part# 73-2623, lot# ni.Unknown screws, part# ni, lot# ni.E4 ¿ refer to mw5093648.

Event Description

This follow-up report is being submitted to relay additional information.It was reported the patient died approximately three (3) days following a redo coronary artery bypass grafting with sternal plating due to a post-operative hemorrhage.Three (3) days after the initial surgery, the patient had massive output from chest tubes, coded and received chest compressions before being brought to the operating room.The patient had an active bleed and a hole in the right ventricle.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.Product was not returned for investigation and no photos, scans, or x-rays were provided; therefore, no visual inspections or functional testing could be conducted.Several attempts were made to obtain more event details including device identification.No additional information was able to be obtained from the sales rep or multiple hospital representatives.As part of this complaint investigation, there were three screw sizers (item# 73-0006) and three sternalock blu trays (item# 73-1300) returned for inspection.All of the screw sizing dimensions on these products were within specification and therefore did not contribute to this complaint.The customer number and item number were searched and 6 possible lot numbers were identified for the 8-hole plate.The non-conformance database was reviewed for each of these possible lot numbers; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this part# 73-2623 for each of the six possible lot numbers (lot# j156030, j797330, j872270, j913670, j979510, j979590) that were distributed to this customer.For this part (73-2623) and the previous one year (from the notification date) regarding improper screw selection, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is improper screw sizing.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.The following fields were updated: b4 date of this report; b5 describe event or problem; d10 device availability; g4 date received by manufacturer; g7 type of report; h2 follow up type; h3 device evaluated by manufacturer; h6 method code; h6 results code; h6 conclusions code; h10 additional narratives/data.

Event Description

This follow-up report is being submitted to relay additional information.

• 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: 9674132
• MDR Text Key: 177922502
• Report Number: 0001032347-2020-00086
• Device Sequence Number: 1
• Product Code: HRS
• 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,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNNOWN
• Device Catalogue Number: 73-2623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/14/2020; 03/03/2020; 07/27/2020
• Supplement Dates FDA Received: 03/10/2020; 03/24/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Death
• Patient Weight: 91