MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 4 HOLE L-PLATE 100 DEGREES; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Chest Pain (1776)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation screw 2.4 x 16 mm cancellous locking, catalog #: 73-2416, lot #: ni; biomet microfixation biomet microfixation screw 2.4 x 14 mm cancellous locking, catalog #: 73-2414, lot #: ni; biomet microfixation screw 2.4 x 12 mm cancellous locking, catalog #: 73-2412, lot #: ni; lorenz plate 8 hole x, catalog #: 73-2623, lot #: ni.Therapy date: (b)(6) 2017.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation because the product was scrapped by the hospital.The investigation is in process.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: 0001032347-2018-00038 through 0001032347-2018-00042.

Event Description

It was reported that eight months post operation, the patient complained of chest pain.A ct scan was performed and revealed sternal dehiscence of ten millimeters in width.A revision was performed; the date of revision is unknown.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs.Product identity could not be confirmed as the products were not returned.Visual inspection and functional testing could not be performed as a result of the products not being returned.The photograph provided by the distributor was labeled "left pic 20170920 right pic 20170314 for the 33-027"; upon review, this indicates that on the right the patient was post-op on (b)(6) 2017, and on the left the patient was post-op on (b)(6) 2017.On the right, it is noted that there appears to be an anterior hard tissue approximation, though this is dependent on the surgeon and should be confirmed prior to closure; while on the left there appears to be an anterior hard tissue separation.This corresponds with the complaint that there was a sternal dehiscence.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.The instructions for use (ifu) for this product states in the section titled possible adverse effects: migration, bending, fracture or loosening of the implant.Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.The ifu also has the following information in the directions for use: determine sternal depth measurement to select appropriate screw length*.Contour plates to patient anatomy, if needed.Align plates such that the cuttable cross-sections span the sternotomy line.Confirm approximation of sternal halves.Fixate plate to bone with the appropriate length screws.If larger diameter screws are needed, 2.7mm screws are available.The following is a recommended implant configuration: manubrium 1 l plate.Body of sternum 1 vertical x-plate.Lower sternum 1 vertical x-plate.Configurations with a minimum of 5 cuttable rigid plate sections (the rigid bars or ties that span the sternotomy line) are recommended to close a complete mid-line sternotomy.Configurations may include a combination of sternalock® 360 devices and sternalock® blu plates with cuttable rigid plate sections.Do not use plates without cuttable rigid plate sections to span a sternotomy.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00038-1, 0001032347-2018-00039-2, 0001032347-2018-00040-2, and 0001032347-2018-00041-1.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 4 HOLE L-PLATE 100 DEGREES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7212171
• MDR Text Key: 97978822
• Report Number: 0001032347-2018-00042
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK011076
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 73-2643
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036141042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR