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

Model Number	A1108
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The lock has rotational and lateral movement and a residue buildup was present, and the teeth on the unit showed some slight wear, but still passed all specific functional testing.The a1018 swivel adapter that was included with the clamp had a big dent in the starburst teeth that was preventing it from lining up with the starburst teeth on the clamp.Root cause - the reported failure "slips during use" was not confirmed.The teeth on the a1108 skull clamp showed slight wear, but still passed all specific functional testing.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2022-00104: a facility reported that the mayfield triad skull clamp (a1108) has worn teeth and slips during use.No patient injury or surgical delay has been reported.

• 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
• 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: 14488277
• Report Number: 3004608878-2022-00105
• Device Sequence Number: 17439798
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A1108
• Device Catalogue Number: A1108
• Device Lot Number: 121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/24/2022
• 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
• Patient Sex: Unknown