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 Patient Involvement (2645)

Event Date 02/27/2020

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 distributor reported on behalf of the customer that the lock position of the a1059 mayfield modified skull clamp could not lock in the right position.There was no patient involvement or delay in surgery.The issue was discovered during the cleaning process on (b)(6) 2020.

Manufacturer Narrative

Udi # (b)(4).The device was returned for evaluation.The device history record (dhr) showed no abnormalities related to the reported failure.The provided lot code 119 indicates a 2011 manufacture date.This device is over 7 years old.Integra¿s recommended product life is 7 years based upon usage as listed in the dhf.A review of previous a1059 complaints related to "lock position" found that upon evaluation of many of these devices, the locks had movement, a residue buildup was present, and worn internal components of the lock required replacement.Given the age of this device, it is possible the reported issues are due to wear and lack of maintenance.However, without a return device, the complaint cannot be confirmed, and the root cause cannot be reliably determined.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 CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10288329
• MDR Text Key: 199311722
• Report Number: 3004608878-2020-00384
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1