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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: (b)(6) 2018.(b)(4).Implant date: (b)(6) 2018.Explant date: (b)(6) 2018.Concomitant medical devices: biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 16 mm, catalog #: 73-2416, lot #: ni; biomet microfixation sternalock blu system plate, 4 hole square, catalog #: 73-2623, lot #: ni; biomet microfixation sternalock blu system plate, 8 hole x, catalog #: 73-2645, lot #: ni; biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 18 mm, catalog #: 73-2418, lot #: ni.Concomitant medical products: therapy date: (b)(6) 2018.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00884 through 0001032347-2018-00888 - [(b)(4)].

Event Description

It was reported on the user facility's medwatch report # (b)(4) that the patient had biomet titanium plates implanted originally in late (b)(6) 2018 on both left and right chest wall due to history of coronary artery bypass graft (cabg) with sterile sternal dehiscence with development of sternal instability.There was no evidence of infection, but the patient did report significant coughing in the early post op period as well as returning to significant weight lifting postoperatively.Several weeks postop, the patient complaint of chest wall instability and pain again and in mid (b)(6) 2018, the patient returned to surgery for redo of bilateral pectoralis major muscle advancement flaps.The plates were observed by the surgeon and appeared to be fractured.Both the plates and screws were removed along with the previous sternal hardware in its entirety and replaced.The patient tolerated the procedure well with no known harm to patient.The original procedure was a revision of rigid sternal fixation.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Reported event was confirmed by review of medwatch report.The parts were not returned for investigation and no photos were provided.For these reasons, the products cannot be visually evaluated or functionally tested.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to either the reported coughing or weight lifting soon after the operation.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.

Event Description

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

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE JL PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8199755
• MDR Text Key: 131512558
• Report Number: 0001032347-2018-00887
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K161896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 73-2645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR