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

Catalog Number A1059

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

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.Linked to mfg report number: 3004608878-2018-00281.

Event Description

This is 1 of 2 reports.A distributor customer reported on behalf of the customer that the torque screw of the a1059 mayfield modified skull clamp came out before surgery on (b)(6) 2018.The skull clamp was in contact with patient but there was no alleged injury.The patient was prepped for surgery and a surgery delay of 30 minutes was noted.No medical revision/intervention was required.Additional information has been requested.

Manufacturer Narrative

The device was returned for evaluation.The heli coil was out of the thread , therefore the index knob was tight to move to lock or unlock.The device history record (dhr) shows no abnormalities relate to the reported incident found nor were there any variances, mrr¿s or reworks associated with this lot/work order number.The complaint reported was confirmed.Root cause is unknown, however the most likely reason, is parent thread had an raised indication formed by an electrical arc / rack mark, most likely caused by an insecure electrical connection between rack and power supply used by anodize supplier.The suspected small pin hole sized indication most likely prevented the helicoil from fully seating allowing the helicoil to work loose.

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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8151470
• MDR Text Key: 130659627
• Report Number: 3004608878-2018-00280
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• 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: 12/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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