MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES INC. V. MUELLER; V. MUELLER TITANIUM ANKENEY STERNAL RETR BLADE 1-1/4 X1-3/8 INCHES 3.2 X3.5CM

Model Number	CH1290
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As indicated, during the inspection of the returned instrument, it was identified that the item had been used and sterilized several times and displayed signs of poor maintenance and possible misuse.The misuse of the instrument, such as twisting, prying, pushing, or other means of applying force, improper maintenance or extended use may have contributed to the damage to the instrument.
Event or Problem Description
On (b)(6) 2024, avalign gsi quality received a customer complaint from steris.Steris reported that they received a complaint from the hospital stating, product snapped in half over patient on table during heart procedure.

• Brand Name: V. MUELLER
• Common Device Name: V. MUELLER TITANIUM ANKENEY STERNAL RETR BLADE 1-1/4 X1-3/8 INCHES 3.2 X3.5CM
• Manufacturer (Section D): AVALIGN TECHNOLOGIES INC.; 626 cooper ct; schaumburg 60173
• Manufacturer (Section G): AVALIGN TECHNOLOGIES INC.; 626 cooper ct; schaumburg 60173
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumburg 60173 ; 8479080292
• MDR Report Key: 20451632
• Report Number: 1421101-2024-00005
• Device Sequence Number: 7204157
• Product Code: DWS
• UDI-Device Identifier: 10885403023705
• UDI-Public: 10885403023705
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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?: No
• Device Model Number: CH1290
• Device Lot Number: C24VIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 10/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown