MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES INC. AVALIGN; KRAY HOOK WITH FINGER RET LARGE BALL TIP TIP 3.5MM OL 185 (7 1/4")

Model Number	VM82-7222
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/06/2024, avalign gsi quality received a customer complaint from steris corporation.Steris corp reported that their customer, the nebraska medical center,reported to them that they had two (2) units of customer part# vm82-7222 that the ball tips broke off during a case.They were removed with no patient impact.

• Brand Name: AVALIGN
• Common Device Name: KRAY HOOK WITH FINGER RET LARGE BALL TIP TIP 3.5MM OL 185 (7 1/4")
• Manufacturer (Section D): AVALIGN TECHNOLOGIES INC.; 626 cooper ct; schaumburg IL 60173
• Manufacturer (Section G): AVALIGN TECHNOLOGIES INC.; 626 cooper ct; schaumberg IL 60173
• Manufacturer Contact: alexis kurz ; 626 cooper ct; schaumberg, IL 60173 ; 8479080292
• MDR Report Key: 20863290
• Report Number: 1421101-2024-00006
• Device Sequence Number: 8785896
• Product Code: GZX
• UDI-Device Identifier: 00190776068103
• UDI-Public: 00190776068103
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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): 12/03/2024

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: VM82-7222
• Device Lot Number: 04012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/06/2024
• 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