MAUDE Adverse Event Report: BIOMET 3I BELLATEK® HADER BAR 4 IMPLANTS

Model Number	CSH04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the bar broke at cylinder #11.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection via naked eye and camera magnification revealed a bar in two pieces.No pre-existing conditions were noted on the product experience report (per).X-ray or picture was not provided.Digital design review: the digital design files were reviewed and the images all appeared within normal limits.The drawing was provided and determined that the design of the bar was cut in the anterior to be within design parameters.The customer was contacted with regard to the intent to cut the bar in two.It is unknown whether parafunctional habits of the patient caused or contributed to the event.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.A lot specific complaint history review was not conducted for patient specific product (psp) complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for this complaint is not performed.Complainant reported that bar broke at cylinder #11.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.

• Brand Name: BELLATEK® HADER BAR 4 IMPLANTS
• Common Device Name: HADER BAR
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12421678
• Report Number: 0001038806-2021-01688
• Device Sequence Number: 3254996
• Product Code: NHA
• UDI-Device Identifier: 00844868001607
• UDI-Public: (01)00844868001607(17)300412(10)8555396-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CSH04
• Device Catalogue Number: CSH04
• Device Lot Number: 8555396-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown