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

Catalog Number A3059

Device Problems Defective Device (2588); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is the first of two reports (same product id, same product problem, same user facility, different patients).This report is in regards to the first patient.Linked to mfg report: 3004608878-2016-00340.Four doctors all felt that the a3059 mayfield composite series skull clamp system is inferior to the old metal systems; specifically in that the 80 lb torque arm side of the c-clamp has flexibility.They described this arm as ¿having a bend¿ to it when the patient is pinned, especially when the torque knob side is below the locking side when attached to the patient and the majority of the patients head weight is applied to this side of the c-clamp.They have tried to work through this issue, however, they feel there is a design flaw that is causing this ¿bend¿.Today they decided the lateral play posed too much risk to the patient and removed the a3059 for an a1059.They have decided to only use the metal a1059 until this problem is resolved.The device was in contact with a (b)(6) male patient.There was no patient injury but there was a 15 minute delay in the surgery due to the product problem.This issue occurred for 2 a3059 skull clamps.

Manufacturer Narrative

This investigation was completed on 12/15/16.The device history record for the unit(s) listed in this complaint under lot code/work order: 157/130500 on 10/07/15.No abnormalities related to reported incident found nor were there any variances, mrr¿s or reworks associated with this lot/work order number.No service history on file.A two year look back for this reported failure and or related to "80 lb.Torque arm side of the c clamp has flexibility " for this product id shows that 2 complaints were received, both reported by same customer.No new design or manufacturing trends have been identified.Engineering and quality were not able to confirm the customer complaint.The part was inspected 100% functionally and it passed all its requirements.The unit¿s rocker arm/swivel assembly interface was rotated on its axis as it was locked and unlocked through 360 degrees.Furthermore, the unit was subjected to the lateral movement test and the force pressure test.Lateral movement test: verify free play of ratchet/clamp base within the limit (must not exceed.200¿).Pressure test: the pressure was checked at 20, 40, 60, and 80 lbs.At intervals +/- 4 lbs.Deviation and it was within specifications.In summary, engineering and quality were not able to verify the customer complaint.The unit was inspected to all the requirements and it passed all.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6149773
• MDR Text Key: 61867667
• Report Number: 3004608878-2016-00339
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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 Age: 69 YR