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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet sternalock blu system plate, 8 hole x catalog #: 73-2623 lot#: ni.Zimmer biomet sternalock blu system screw, cancellous cross-drive locking 2.4 x 16mm titanium catalog #: 73-2416 lot#: ni.Zimmer biomet sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm titanium catalog #: 73-2414 lot#: ni.Zimmer biomet sternalock blu system plate, 8 hole jl-plate catalog #: 73-2645 lot#: ni.Device evaluated by mfr: 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.Multiple mdr reports were filed for this event; please see associated reports: 0001032347-2019 -00210, 0001032347-2019 -00212, 0001032347-2019 -00213, 0001032347-2019 -00214.
Event or Problem Description
It was reported that a revision was performed due to the screws pulling out of the bone resulting in sternal separation.The patient's sternum was originally closed with wire after a cardiac surgery approximately two months prior to implantation of sternalock.The wires failed and sternalock was implanted as a result.The patient reported that he felt pain and instability while at a gun range and it was determined via x-ray that the screws had pulled away from the sternum on one side.Subsequently, all sternalock plates and screws were removed.The surgeon advised that he does not believe that this issue was related to the device.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.As there was a revision to remove and replace these parts, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts being discarded, and no photographs, x-rays, ct scans, or physician reports being provided.The dhr could not be reviewed for the plates and screws as the lot numbers are unknown.There are no indications of manufacturing defects.For all plate 4 hole l 100 deg (part# 73-2643) in the previous year (from the notification date), there is a complaint rate of 0.007%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.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, 4 HOLE L-PLATE 100 DEGREES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8483776
• Report Number: 0001032347-2019-00211
• Device Sequence Number: 16624747
• Product Code: HRS
• UDI-Device Identifier: 00841036141042
• UDI-Public: 00841036141042
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 73-2643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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