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

Catalog Number A1059

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This report is 1 of 3 linked to mfg report numbers: 3004608878-2024-00040, 3004608878-2024-00041.A facility reported that there was an issue (movement) with the mayfield modified skull clamp (a1059) during craniotomy surgery.The patient was already under anesthesia when the dysfunction was observed; however, there was no consequences/impact for the patient.The surgery was finalized using a replacement unit with approximately 5 to 10 minutes increased surgery time (time to find another skull clamp).The only biographic information received is that the patient was an adult.

Manufacturer Narrative

The mayfield skull clamp (a1059) was returned for evaluation: failure analysis - the inspection of the skull clamp shows it has rotational movement in its swivel lock assembly and a residue buildup was present.For the adjustment of the lock assembly, new components were required to replace worn internal parts.To resolve all issues, the internal parts of the unit were replaced to adjust it according to manufacturer specifications and to clean the skull clamp's swivel lock assembly.After completing the reassembly, including the adjustment, the skull clamp was subjected to a successful function test.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is routine use and wear.The unit is beyond integra¿s 7 years recommended life cycle and required replacement of worn internal components and cleaning of residue buildup.Additionally, improper, or suboptimal placement of the skull clamp can contribute to slippage/movement of 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 MODIFIED SKULL CLAMP
• Type of Device: 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: 18994825
• MDR Text Key: 339335940
• Report Number: 3004608878-2024-00039
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 169
• Date Manufacturer Received: 03/06/2024
• 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
• Treatment: A1064 MAYFIELD BALL SOCKET SWIVEL ADAPTOR.; A2101 MAYFIELD ULTRA BASE UNIT.