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

Model Number	A1114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Initially, a facility reported to our service & repair team that the locking mechanism on the mayfield infinity skull clamp (a114) for securing the head pin was not holding.The facility did not report if there was patient involvement, injury, or surgical delay relative to this failure.Subsequently medwatch uf/ importer report # (b)(4) was received on 21sep2022 with the following information: "mid teen¿s teenage male diagnosed with a brain mass.Plans were made for elective resection after a discussion of risks and benefits was held with his family who agreed to proceed.Surgery started and approx.2hrs in the pt's head moved, pt checked.Pt's head was found to have partially slipped out of the mayfield head holder with left side of face pressed against metal mayfield head holder.Head holder was subsequently removed and replaced with a horseshoe pillow mayfield attachment.Metal mayfield head holder was tested for malfunction by neurosurgery specialist tech and found to be intact without issue.Surgeons continued surgery as patient seemed unharmed by the event at the time.End of case the pins, which were left in, were removed.Upon removal, it was found that the pin on the left lateral side of the skull had caused a 12 cm injury that required further surgical intervention." additional information is being requested.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation showed that the lock had rotational and lateral movement and a residue buildup was present.The index knob was loose and the unit required replacement of worn components due to routine use and wear.General maintenance and cleaning performed, and new components were added to replace worn internal parts.Root cause - the complaint is confirmed via inspection of the unit.Additionally, improper or suboptimal placement of the skull clamp on the patient can contribute to slippage/movement of the head in the skull clamp.No corrective or preventative action is required and none has been issued within the past 12 months for the same issue.This will be monitored and trended going forward.

• Brand Name: MAYFIELD INFINITY 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: 15471694
• Report Number: 3004608878-2022-00197
• Device Sequence Number: 11492724
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• 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): 09/22/2022

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: A1114
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• 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 Age: 16 YR
• Patient Sex: Male