MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A

Model Number	A1114A
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity skull clamp 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 lock had rotational and lateral movement and required replacement of worn internal parts.Root cause -complaint confirmed via inspection of the unit.The lock had rotational and lateral movement and required replacement of worn internal parts as a result of routine use and wear.Additionally, improper or suboptimal placement of the skull clamp on the patient can contribute to slippage of the patient in the pins.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
Medwatch with mdr report #(b)(4) was received: "patient in operating room for craniotomy for tumor excision.Patient position with mayfield skull clamp during case by md.During skin closure, patients head slipped out of pins causing a 0.5 inch and 0.25 inch laceration on forehead.Laceration sutured closed." additional information was subsequently received: per the physician's notes: ¿after thorough preoperative evaluation, this patient was brought to the operating room placed on the operating table in a supine position.Her left shoulder was gently bumped using a shoulder roll, and the head turned to the right thus exposing the temporoparietal area.Her head was affixed in a mayfield head holder.¿ the patient was not repositioned.Approximately 2.5 hours was the length of time the product was in use before the event occurred.60-65 pounds pressure was applied to the patient.There was no delay in surgery reported.Patient was removed from the mayfield and normal padded or head piece was replaced after incision was closed.Physician assistant closed 1 site with suture and 1 with staples.The other site did not require closure.Lacerations were either sutured or stapled for closure and dressings applied.

• Brand Name: STANDARD INFINITY 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: 14396035
• Report Number: 3004608878-2022-00096
• Device Sequence Number: 1982056
• Product Code: HBL
• UDI-Device Identifier: 10381780253556
• UDI-Public: 10381780253556
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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: A1114A
• Device Catalogue Number: A1114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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: 45
• Patient Sex: Female