MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP LOANER; N/A

Catalog Number A1059P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on 16jan2018.The device has been cleaned and inspected.Cleaning and testing in order to confirm full function to manufacturer¿s specifications.No fault found with rocker arm or skull pin receptacles.Device history record (dhr) review could not be perform at this time since the product was made before this part number was serialized.However, dhr for the un-serialized product were reviewed and found no nonconformance or abnormalities.The customer issue was not confirmed.The root cause is undetermined.

Event Description

It was reported that on (b)(6) 2017, an a1059p mayfield modified skull clamp loaner was set up on the patient for a craniotomy.However, only one pin on the rocker arm went into the skull.The single arm pin was okay.There was no patient injury or delay in surgery.Another skull clamp was available and it was used to complete the surgery.Additional information was received on 11jan2018 with the following: the customer used the same reusable stainless steel pins that they had in the original skull clamp; took them out of the that mayfield skull clamp and placed them in the other mayfield skull clamp.They were able to use the same pin holes in the skull.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP LOANER
• Type of Device: N/A
• 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: 7224521
• MDR Text Key: 98643328
• Report Number: 3004608878-2018-00005
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059P
• Device Lot Number: L000298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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