MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 04/13/2021

Event Type  Death  

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

A facility reported that after applying the mayfield skull clamp (a2114) to a patient for an emergency craniotomy procedure, the two pin side broke off.The patient's head slipped and resulted in laceration from head to nose.There was a delay in surgery due to product problem for 15 minutes.Additional information received indicates that the event occurred during positioning, and that the laceration to the patient was sutured at the end of the case.The patient was reported as unstable after the procedure and subsequently expired.Additional information is being requested in relation to patient outcome.

Event Description

N/a.

Manufacturer Narrative

Additional information received - facility has advised that the patient was unstable prior to the emergency craniotomy which was performed as a result of a ruptured aneurysm.After applying the skull clamp, the 2 pin side of the rocker arm broke off and the patient's head slipped.Integra a1120 adult disposable pins were concomitantly used for the procedure.The date of the patient's death is (b)(6) 2021.Investigation findings - an evaluation of the actual mayfield skull clamp could not be performed because the device was not returned by the facility.However, lot number was provided; therefore, device history records were reviewed which revealed no anomalies related to the reported failure.Medical assessment - based on the reported complaint information reviewed to date, the product and product performance issues were not seen to be associated with the demise of the patient.The patient suffered a ruptured aneurysm that warranted an emergency craniotomy.The patient was already in an unstable state prior to the surgical procedure and use of the mayfield device and remained unstable after the completion of the surgical procedure.The user facility physician has not attributed the patient's death to the device incident.

Manufacturer Narrative

Corrected fields: h6, h10 (investigation findings in follow up mdr #1).Investigation findings - mayfield infinity skull clamp (a2114) was not returned for evaluation; however, the customer provided a photo of the device involved in the incident.The visual inspection of the photo showed that the pin broke off on one of the arm of the skull clamp.The nature of the observed breakage is consistent with excessive force or improper handling, positioning and alignment of the device.When the device is properly positioned, aligned, and put under pressure according to the device ifu (instructions for use), the pin would not have broken.Additionally, the lot number was provided; therefore, device history records were reviewed which revealed no anomalies related to the reported failure.

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11790216
• MDR Text Key: 249460583
• Report Number: 3004608878-2021-00338
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 11/05/2021
• Supplement Dates FDA Received: 05/26/2021; 11/09/2021
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INTEGRA A1120 ADULT DISPOSABLE PINS
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Sex: Female