MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2024

Event Type  Injury  

Event Description

This is 2 of 2 reports linked to mfg report number 3004608878-2024-00032: a facility reported that during an unspecified case, the mayfield composite series skull clamp (a3059) slipped, resulting in injury to the patient.Additional information has been requested.

Manufacturer Narrative

The mayfield composite series skull clamp (a3059) was returned for evaluation.Device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - evaluation of the returned unit was unable to duplicate slippage as the unit passes all specific functional testing.However, the unit has a stiff rocker arm assembly and does not rotate easily; it is recommended that the unit receive preventive maintenance (pm).As a result, the disk ratchet and retainer will be replaced and general cleaning and maintenance performed.Further, the unit was sent to quality engineering for further investigation due to reported injury, and the initial findings were confirmed by quality engineering (the rocker arm had stiff movement and some wear was noted on the starburst teeth).No additional device deficiencies were observed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint as slippage could not be duplicated.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: 18896024
• MDR Text Key: 337574385
• Report Number: 3004608878-2024-00033
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1