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

Catalog Number A1059

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by 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 a broken locking mechanism of the a1059 mayfield modified skull clamp.There was no patient involvement or surgery delay.

Manufacturer Narrative

Unique device identifier (udi) #: (b)(4).Sample was received for evaluation.Device history record (dhr) - no record found for lot code 057.This unit is over seven (7) years old.Integra's recommended product life is seven (7) years based upon usage as listed in dhf (manufactured in 2005).Failure analysis - the unit was received with the lock having both rotational and lateral movement and was hard to lock with a residue buildup present.The teeth were worn on the base and needs replaced.Upon disassembly, repair noted the lock needed new components added to replace worn internal parts.The unit was received without the ratchet extension arm and the 80# torque knob.The price does not reflect the replacement of the ratchet extension arm or the 80# torque knob.Complaint confirmed via inspection of the unit.The lock had movement while locked, was difficult to lock, and required replacement of worn internal components.Issues due to repeated use and wear.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.

• 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: 10532917
• MDR Text Key: 207167563
• Report Number: 3004608878-2020-00527
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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
• Device Lot Number: 057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1