MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

A facility reported a perforator (id (b)(4) "worked poorly and got stuck in the bone and bone dust".Product was in contact with the patient; however, no patient injury reported and the event did not led to surgical delay.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Additional information received: -what is the lot number? answer : 5580821 -how did the medical staff remove the perforator and finish the procedure? answer : normally removed (the surgery proceeded with diamond cutter) -could you please confirm the dysfunction did not lead to increase surgery time for more than 30 minutes? answer : less than 30mins -after how many time of use the dysfunction was observed ? answer : shortly after the beginning of usage of perforator -is the patient an elderly person, an adult, a child or a baby? answer : adult/ elder -what is the manufacturer of the drill used with the perforator? answer : bienaur osseoduo -was the drill electric or pneumatic? answer : electric 80000 -did the perforator click in place in the drill? answer : yes -are the recommended spring tests being performed between each burr hole? answer : yes additional information received april 17, 2024: "after placing the perforator burr on the handpiece and starting cranial perforation, the drill stopped despite not having perforated the entire bone layer.It had to be removed manually the residue causing lengthening of the surgical time.A diamond bur + kerrison was used to remove the remaining layer of bone.It was not possible to keep the dm subject of the report.".

Manufacturer Narrative

Additional information received: "after placing the perforator bur on the handpiece and starting cranial perforation, the drill stopped despite not having perforated the entire bone layer.It had to be removed manually the residue causing lengthening of the surgical time.A diamond bur + kerrison was used to remove the remaining layer of bone.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18966512
• MDR Text Key: 338436784
• Report Number: 3014334038-2024-00059
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 5580821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL: BIENAUR OSSEODUO.