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

Model Number	A1117
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
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 broken parts of the mayfield skull clamp (a1117) was discovered during an unspecified surgical procedure - patient was under anesthesia.The medical staff finished the surgery by closing punctually the patient's wound (surgical site) to re-position the patient in the skull clamp.As a result, there was infectious risk to the patient.There was increased surgery time of 4+ hours due to the repositioning of the patient in the headrest, re-matching of the neuronavigation, reshaping and resumption of surgical action.
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 reported complaint was confirmed from the evaluation.The torque knob was received glued back together, and the force gage cap and torque screw were glued together by the customer or someone else.The keepers were replaced due to having too much wear.The pine kit box was missing the treaded engagement shaft so it was replaced along with the thumb screw and crosscut piston.Unit required replacement of broken and worn components.Root cause -probable root cause is damage from mishandling or rough handling of the unit.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: 15764062
• Report Number: 3004608878-2022-00237
• Device Sequence Number: 6227226
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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?: Yes
• 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/20/2023
• 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