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

Catalog Number	A2114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit is unable to duplicate slippage and passes all specific functional testing.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - evaluation found no device deficiencies that would contribute to the reported complaint.When the clamp is properly positioned and put under pressure, it would not slip.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.No corrective action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that the patient's head slipped in the mayfield infinity xr2 skull clamp (a2114) causing a laceration that had to be washed out and cleaned with betadine, then sutured.The patient was in prone position when the pins slipped at 70 pounds of pressure.Additional information was received as follows: 1.Please provide the size and location of the laceration.>> the laceration was not measured per the op note.2.What type of procedure/surgery was performed during the incident? >> - suboccipital craniotomy for resection of cerebellar arteriovenous malformation - frameless, stereotactic, image-guided, intradural neuronavigation - use of operating microscope for arachnoidal and aneurysmal microdissection - intraoperative digital subtraction cerebral angiogram 3.Was there a delay in surgery due to product problem? if yes, how long (in minutes)? >> about 45 minutes delay due to patient repositioning and suturing of laceration.4.How was the procedure completed? >>the patient was in prone position when the pins slipped, patient¿s lacerations were sutured and the patient was repositioned.Surgery proceeded and was completed.5.Please provide patient outcome.>> patient incurred unintended injury.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Common Device Name: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19957540
• Report Number: 3004608878-2024-00093
• Device Sequence Number: 8897887
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American