MAUDE Adverse Event Report: BIOMET MICROFIXATION SL360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Wound Dehiscence (1154); Cough (4457)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported that the patient had a cags approximately five weeks ago and his sternum was closed with sternalock 360.The patient has a bmi of 41.5 - 170cm and (b)(6) kg.During the primary case, the standard sl360 configuration was used.No additional anterior plates were implanted between the manubrium and the second plate at the 3rd intercostal space nor was additional wiring employed at the xiphoid process.The patient was brought back to the or due to sternal dehiscence as he had broken the titanium band (thought to be as a consequence of coughing).

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product - unknown screws catalog#: ni lot#: ni.Report source: foreign - (b)(6).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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images assessed but not sent to mmi, plain film xrays would provide better view- ct slices would not enhance the investigation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SL360 MULTI-IMPLANT SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13417351
• MDR Text Key: 284829197
• Report Number: 0001032347-2022-00042
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 633290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 120 KG