MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Medical products: unknown screws, part# ni, lot# ni.
Event or Problem Description
It was reported a revision occurred fourteen days following implantation of sternal closure plates and bands due to an unspecified implant failure.Attempts have been made but no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because a revision surgery was reported.The device was not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or inspections could be performed.The dhr for this device could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.The most likely underlying cause of the complaint cannot be determined, as it is unclear how the sl360 system failed and led to the need for a revision surgery.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 360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9905653
• Report Number: 0001032347-2020-00189
• Device Sequence Number: 19515982
• Product Code: HRS
• UDI-Device Identifier: 00841036190668
• UDI-Public: 00841036190668
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 74-0004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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