MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number	A1114
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to mfg report 3004608878-2023-00205: a facility reported that when they attempted to use this mayfield infinity skull clamp (a1114) for a third time, it could not be used in the operating room (presence of integra rep in the room) due to a malfunction: difficult to close the arm and impossible to tighten correctly.The operation ended with another mayfield they had in stock and a delay of 90 minutes.There was no patient injury.
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
The mayfield modified skull clamp (a1114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The swivel lock opens and closes according to the manufacturer's specifications; there is no movement.The starburst teeth and inner threads have no defect, and the ratchet extension can be inserted fluidly into the skull clamp base and can be unlocked properly.The swivel base assembly rotates smoothly throughout the 360° rotation, the index knob has a positive rollover, and the plunger assembly does not contain any free movement when the ratchet extension is removed.No maintenance is required at this time, as the unit met all manufacturer specifications.The unit has been subjected to a successful functional check, and the device has been scrapped.Root cause - the complaint is not confirmed.The returned unit is in good working order and meets all manufacturer¿s specifications.Probable root cause is improper use or customer error.No further investigation 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.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Common Device Name: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 18152930
• Report Number: 3004608878-2023-00208
• Device Sequence Number: 20828707
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Catalogue Number: A1114
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• Patient Sex: Unknown