MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

It was reported that while adjusting the head positioner, it slipped and caused a laceration on the scalp.There was no surgery delay.Additional information has been requested.

Manufacturer Narrative

Integra completed its internal investigation 09/27/2016.The investigation included: method: device history review.Trend analysis.Evaluation of product.Results: device history record reviewed for this product id under lot code/work order (b)(4) show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mrr¿s, variances or rework.No previous service history is on file.No manufacturing or design related trend has been identified.Engineering inspected the part¿s lock/unlocking mechanisms and torque screws¿ output forces.Skull clamp was mounted onto the fixture and got assembled with a wooden block.The starbursts¿ threads from both sides work perfectly.Skull clamp¿s lock/unlock mechanism works fine as intended and the swivel rotates on its axis.Also, the torque screws were checked at 20, 40, 60, and 80 lbs.At intervals +/- 4 lbs.Deviation and both were within specifications.Also, no looseness was experienced during this checkup.Unit received with the knob insert assembly unscrewed over the black o-ring and has become stuck.Conclusion: engineering was not able to confirm the customer complaint about the skull clamp slippage.All the necessary inspections were performed and none of the characteristics malfunctioned.The mayfield patient positioning for success chart has been provided to the customer as a refresher tool.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5910450
• MDR Text Key: 53359936
• Report Number: 3004608878-2016-00236
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Device Lot Number: 161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR