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

Catalog Number	A1108
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during an unspecified procedure, the patient's head moved in the mayfield triad skull clamp (a1108), and it was observed that the patient's face was pressed against crossbar and there was a laceration on the side of the patient's head.Additional information was subsequently received as follows: 1.Please provide patient information: a.Date of birth: >> unwilling to share b.Gender: >> unwilling to share c.Ethnicity (hispanic/latino, not hispanic/latino): >> unwilling to share d.Race (asian, american indian or alaskan native, black or african american, white, native hawaiian or other pacific islander) >> unwilling to share.2.What type of procedure was performed? >> posterior cervical.3.Please provide the size and location of the laceration.>> left side, behind ear, approximately 4 inches.4.Was there a delay in surgery due to product problem? if yes, how long? >> caused at least 1hr delay or more during the case.5.Was there a revision/medical intervention required? >> stitches and wound care post-op.6.How was the procedure completed? >> repositioned two separate times and continued with the procedure.7.Patient outcome/current condition? >> unknown.
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis - the investigation was unable to duplicate the reported issue.The clamp is over 20 years old and was last serviced more than 10 years ago; therefore, it can no longer be serviced by the repairs department and will be returned to the customer without being repaired.Since the unit was involved in a patient injury, it was sent to quality engineering (qe) for further investigation.Qe confirmed the initial findings of the service & repair report and noted that there was minor movement noted in the index knob which was an older style; also, the helicoil was protruding from the ratchet extension.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The clamp is over 20 years old and was last serviced more than 10 years ago.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp.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: MAYFIELD TRIAD 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 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: 19767081
• Report Number: 3004608878-2024-00081
• Device Sequence Number: 8541569
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: A1108
• Device Lot Number: 044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG