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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the a1059 mayfield modified skull clamp, ¿the pin may not be secure'.Additional information received on 16jan2020 stated that the device was used in a craniotomy hematoma procedure.The product problem (fault) was discovered after the device was attached to the patient.There were a few minutes delay in surgery, however there was no patient harm reported.The action that was taken after the product problem occurred was that the device was taken out of service and replaced with another skull clamp.

Manufacturer Narrative

Device identifier (b)(6).The device was returned for evaluation.The device history record (dhr) was reviewed with no abnormalities related to the reported failure.The 196 devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The investigation and functional testing of the returned a1059 mayfield modified skull clamp confirmed the reported condition.The lock of the unit was having both rotational and lateral movement and a residue buildup is present.Further evaluation showed that the index knob and the lock had worn parts and replacement is needed.The unit also needs to be machined to have heli-coils added to large starburst threads; the set screw in the swivel base was tight.The reported condition and observed condition is likely caused by wear and tear over time / improper handling of the unit.

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 45227
• MDR Report Key: 10277519
• MDR Text Key: 202957894
• Report Number: 3004608878-2020-00069
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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 Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1