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

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint(b)(4).Concomitant medical products- biomet microfixation sternalock screws, catalog #: ni, lot #: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient does not wish to return them.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision due to loosening.During a visit to a chiropractor, the patient was advised that several screws were loose and one screw was just floating around, confirmed by ct scan.During the revision, the lower plate and screws were removed.The patient stated the two upper plates and screws were also loose, but remained implanted because there would be nothing holding the patient together.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.These parts were removed in a revision, therefore, the complaint is confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.For all plate 8 hole x implants (part# 73-2623) in the previous year (from the notification date), the total complaint rate is 0.18% which is no greater than the occurrence listed in the application fmea.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE X
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8481191
• Report Number: 0001032347-2019-00199
• Device Sequence Number: 11017731
• Product Code: HRS
• UDI-Device Identifier: 00841036141028
• UDI-Public: 00841036141028
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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 Model Number: N/A
• Device Catalogue Number: 73-2623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 08/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR