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

Model Number A1059

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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

A facility reported that a patient had an injury (wound) involving the mayfield modified skull clamp (a1059).Information received indicates that 1 pin moved.Additional information has been requested.

Manufacturer Narrative

The mayfield skull clamp (a1059) 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 it was missing its serial no label, it has the lot 184.The unit was mixed up, only the 80 lb.Torque screw is marked with the no.(b)(6).The swivel assembly was loose and had movement present.The 80-pound torque knob could not be turned smoothly, and the index knob had stuck bearing balls.To resolve all issues, the small parts were replaced along with the swivel lock assembly and the index knob.Also, deep cleaned and reassembled the swivel lock assembly, adjusted the mechanism according to manufacturer specifications, performed a function test of the skull clamp and marked all parts with the instance no.Root cause - the complaint is confirmed via inspection of the unit.Unit required replacement of worn components due to routine use and wear.Additionally, improper or suboptimal placement of the skull clamp can contribute to movement or slippage of the patient.No further investigation 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.

Event Description

N/a.

• 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: 15955346
• MDR Text Key: 305235577
• Report Number: 3004608878-2022-00270
• 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,Followup
• Report Date: 02/09/2023

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
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2018
• 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