MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number A1059

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

A facility reported that the lock on the mayfield modified skull clamp (a1059) is broken and the ratchet has too much play side to side.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - unit received with the lock having rotational and lateral movement and a residue buildup was present.The movement of the ratchet extension was within tolerance.General maintenance performed and new components were added to replace worn internal parts.Root cause - complaint confirmed via inspection of the unit.The lock had rotational and lateral movement and a residue buildup.Unit required cleaning and replacement of worn parts due to routine wear and tear.Unit is beyond integra's 7 years recommended life cycle (manufactured in 2009).However, the movement of the ratchet extension was within tolerance.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12846124
• MDR Text Key: 286062806
• Report Number: 3004608878-2021-00638
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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