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

Model Number	A1108
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The unit was unable to be tightened down all the way.The ratchet extension was from our loaner a1108p-18p.The ratchet extension was sticking on the plunger stud and the lock was loose.The slippage could not be duplicated.Further investigation by quality engineering confirms the findings of the service & repair team's evaluation that ratchet extension was sticking, and the lock was loose.Root cause -complaint confirmed via inspection of the unit.The unit was unable to be tightened down all the way.The ratchet extension was from a loaner unit a1108p-18p.The ratchet extension was sticking on the plunger stud and the lock was loose, requiring replacement of worn internal parts from routine use and wear.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2010).The reported slippage could not be duplicated; however, improper or suboptimal placement of the skull clamp can contribute to slippage 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.
Event or Problem Description
A facility reported that during a posterior fossa tumor resection procedure, the mayfield triad skull clamp (a1108) would not tighten down all the way and stay secure.It slipped while on patient, causing a cut/injury on the right side of the patient's head, approximately "1 1/2 to 2" long.There was a delay of 30 to 45 minutes as the surgeon stapled the wound 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
• 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: 14627721
• Report Number: 3004608878-2022-00116
• Device Sequence Number: 5077332
• 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): 06/07/2022

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: A1108
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/07/2022
• 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