MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA GE MR/CT SKULL CLAMP; N/A

Model Number	A1117
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/29/2022
Type of Reportable Event	Serious 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.
Event or Problem Description
A facility reported that during use of the mayfield skull clamp (a1117), the head of the patient slipped during surgery causing a laceration.They stopped the surgery to suture the laceration.Facility also indicated that the force applied do not match to the force indicated (pressure issue).No increased surgery time was reported.
Additional Manufacturer Narrative
The mayfield skull clamp (a1117) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device showed that the received skull clamp had missing and broken parts that required replacement.Unit had a cross cut piston long replaced due to not being received with the unit.The transfer board knobs were replaced due to not being received with the unit.The keepers on the skull clamp were replaced due to showing heavy wear.The traded engagement shaft in the blue case was replaced due to having a broken tab.General maintenance and cleaning performed -unit was cleaned as a pm.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is rough handling or mishandling of the unit.Additionally, improper or suboptimal positioning of the skull clamp on the patient can contribute to slippage of the patient's head.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: GE MR/CT SKULL CLAMP
• Common Device Name: N/A
• 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: 14593849
• Report Number: 3004608878-2022-00115
• Device Sequence Number: 5811045
• Product Code: HBL
• UDI-Device Identifier: 10381780253600
• UDI-Public: 10381780253600
• Combination Product (Y/N): N
• PMA/510(K) Number: K081401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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 Model Number: A1117
• Device Catalogue Number: A1117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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