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

Catalog Number A1059

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 torque knob of the a1059 mayfield modified skull was loose and grinded.The ratchet mechanism did not ratchet smoothly.There was no known patient injury or surgery delay.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The device was returned for evaluation.Device history record (dhr) - no abnormalities related to the reported failure shown in dhrs found for lot# 127.Failure analysis - upon evaluation, the ratchet extension arm would not go through the base of the returned unit smoothly.The 80# torque knob was grinding.The lock had rotational and lateral movement and a residue buildup was present.Unit needed new components added to replace worn internal parts.Complaint confirmed via inspection of the unit.With respect to the complaint, it was confirmed the returned unit did not meet all specific functional tests.The torque knob was grinding, and the ratchet arm did not move smoothly.

• 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: 10553966
• MDR Text Key: 207547826
• Report Number: 3004608878-2020-00554
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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: 127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1