MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Catalog Number	261222
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a perforator failed to disengage causing cerebral contusion and opening of the meninge.It was treated with coagulation of the cerebral cortex and intraparenchymal hematoma evacuation.The event led to 10 minutes surgical delay.Patient consequences: proprioceptive ataxia (gait disturbances).
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.The unit was heavily soiled with organic material, it had bone fragments lodged between the inner and outer drill.The label was destroyed.Ifu testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Additional information received: when the patient was discharged on september 5, the doctor reported the following comments: "neurologically we find a coherent and oriented patient, presenting no language disorder.The patient evokes an altered spatial perception, great fatigue, but also concentration disorders.This hemineglect and left hemiparesis persists with a defect grip, but in good recovery thanks to physiotherapy.The patient also mentions coordination problems when carrying out certain tasks.He has no headaches, nor any other sign of intracranial hypertension.There is no comitial crisis." "this patient did not have consultation at our center since.".
Event or Problem Description
N/a.

• Brand Name: CODMAN 11MM DISPOSBL PERFORATR
• Common Device Name: 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 ; 6099362319
• MDR Report Key: 17549887
• Report Number: 3014334038-2023-00137
• Device Sequence Number: 12504414
• Product Code: HBF
• UDI-Device Identifier: 10381780513605
• UDI-Public: 10381780513605
• Combination Product (Y/N): N
• PMA/510(K) Number: K071931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 261222
• Device Lot Number: 7221965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown