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

Catalog Number	A1114A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that during a craniotomy, they could not get the plunger out of the standard infinity skull clamp (a1114a) to unlock the patient, but the torque knob was still tightened.The issue was resolved by loosening the knob and they were then able to pull the plunger to unlock the patient.There was no technical delay other than the team adjusting/changing out the mayfield for another; however, the surgeon did need to stitch a small scalp laceration from the pins.There was no change in the surgical outcome of the patient.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114a) was returned for evaluation.Device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that there were welts on the ratchet extension filed down to allow the extension to move smoothly through the body casting.Additionally, the lock on the clamp had movement and was loose.To resolve all issues, the worn internal components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - the reported complaint confirmed via inspection of the unit.The ratchet extension was sticking due to welts on the extension from having other devices attached to the ratchet extension.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.
Event or Problem Description
N/a.

• 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: 17924103
• Report Number: 3004608878-2023-00189
• Device Sequence Number: 16846709
• Product Code: HBL
• UDI-Device Identifier: 10381780253556
• UDI-Public: 10381780253556
• 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,Followup
• Report Date (Section B): 11/30/2023

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 Catalogue Number: A1114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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