MAUDE Adverse Event Report: ALLERGAN (KELLER) KELLER FUNNEL2 (5PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-005
Medical Device Problem Code	Inadequate Lubrication (4057)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: n/a; "device would not allow an implant to slide in despite being cut to correct marking for implant size and appropriate lubrication.Very sticky and stiff at end of the funnel.".
Event or Problem Description
Healthcare professional reported device "would not allow an implant to slide in despite being cut to correct marking for implant size and appropriate lubrication.Very sticky and stiff at end of the funnel." surgery was completed with a backup device.

• Brand Name: KELLER FUNNEL2 (5PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 1239 se indian st; ste 112; stuart FL 34997
• Manufacturer (Section G): ALLERGAN (KELLER); 1239 se indian st; ste 112; stuart FL 34997
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 78759 ; 7722199993
• MDR Report Key: 19792796
• Report Number: 3011299751-2024-00103
• Device Sequence Number: 4198024
• Product Code: KDD
• UDI-Device Identifier: 10888628043732
• UDI-Public: 10888628043732
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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: Health Professional
• Device Expiration Date: 08/10/2025
• Device Catalogue Number: HA-005
• Device Lot Number: 23H09C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White