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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in november or december 2018.Concomitant medical products: medical product - zimmer biomet sternalock screws catalog #: ni lot #: ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.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 several screws loosened from the plates approximately five to six months post-implantation.The patient's sternum was originally closed with wire after a bypass surgery.The patient experienced a non-union and as a result, underwent a revision during which his sternum was again closed with wire.After experiencing a second non-union, the patient underwent a second revision during which his sternum was closed with sternalock blu.During a visit to a chiropractor, the patient was advised that several screws were loose and one screw was just floating around.A ct scan was performed and confirmed that the screws were loosened.A revision was performed during which one plate and eight screws were removed from the xiphoid region of the patient's sternum.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of post-operative ct scans and x-rays.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 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• 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: 8481206
• Report Number: 0001032347-2019-00200
• Device Sequence Number: 1019619
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 08/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: Other
• Patient Age: 54 YR