MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16 MM; SCREW, FIXATION, BONE

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: biomet microfixation sternalock blu system plate, 12 hole jl-plate, catalog #: sp-3215, lot #: ni; biomet microfixation sternalock blu system sternalock 6 hole hex plate; catalog #: sp-2890, lot #: ni; biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 12, catalog #: 73-2412, lot #: ni; biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 14 mm, catalog #: 73-2414, lot #: ni; therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00897 through 0001032347-2018-00900.

Event Description

It was reported a re-operation was performed the same day the devices were implanted due to cardiac complications.The surgeon removed and re-implanted the same product.There was no allegation of any issue related to the sternalock devices according to the distributor.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event is considered confirmed as a revision was reported.The product was not returned for investigation and no photos were provided.For these reasons, the implants 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 patient condition.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 report is being submitted to relay additional information.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16 MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8199838
• MDR Text Key: 131514158
• Report Number: 0001032347-2018-00901
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention