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

Catalog Number A3059

Device Problem Mechanical Problem (1384)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/21/2021

Event Type  Injury  

Event Description

A facility reported that the black swivel base on the mayfield composite series skull clamp (a3059) does not rotate, swivel could not be turned at the lock position and it was still unlocked.The patient pins was in place in the scalp when the surgeon tried to lock the black swivel base.The neurosurgeon changed the a3059 mayfield skull clamp pinned in patient scalp for another a1059 mayfield modified skull clamp.There was a delay in surgery for 10 minutes with no patient 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.

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: the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Unit received with the mayfield 2 lock having up and down movement.The index knob was cracked on the inside and is not allowing it to go into the locked position.The index knob was replaced and all worn components were replaced with new parts.Root cause: the complaint is confirmed via inspection of the unit.The index knob was cracked on the inside and would no go into the locked position.The lock had movement and required replacement of worn components.Probable root cause is rough handling resulting in damage to the knob.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

Manufacturer Narrative

Updated fields: g3, g6, h2, h10, h11 this mdr is being submitted for an error which was submitted in follow up mdr #1."type of reportable event" should have read "serious injury.".

Event Description

N/a.

• 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: 12807533
• MDR Text Key: 284691191
• Report Number: 3004608878-2021-00629
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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?: Yes
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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