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

Catalog Number A1059

Device Problems Disassembly (1168); Material Separation (1562)

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

Event Date 11/05/2015

Event Type  malfunction  

Event Description

The mayfield modified skull clamp came apart in the surgeon's hands.There was no report of adverse outcome or injury to the patient.Surgery delay was 30 minutes.Type of surgery was a transsphenoidal hydrosectomy.Additional information was requested and on 26 nov 2015, the following was provided: there was no further information of how the skull clamp "came apart" in the surgeon's hands.The surgery delay was the estimated time of attaching a replacement mayfield skull clamp.There was no adverse consequence due to the delay.A replacement product was available to be used and surgery was completed.

Manufacturer Narrative

Integra completed its internal investigation 01/05/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: returned unit was received still assembled, however, excessive movement found in swivel base when index knob is locked.All related components including swivel base, round head screw and adjustment screw have been replaced to eliminate the excessive movement as identified.During testing, torque screw was found to not meet manufacturer¿s specifications and has been replaced free of charge.Device has been serviced, meets manufacturer¿s specifications and is now ready for clinical use.This device was manufactured on september 30, 2011 and a review of dhr's containing lot code 117 showed that the following lots passed the required inspection points without mrr's or variances service history: date of service: (b)(6) 2015.No new design or manufacturing trends have been identified.Conclusion: in summary, the end users experience could not be duplicated or verified.General maintenance was required of this returned device.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5255669
• MDR Text Key: 32476704
• Report Number: 3004608878-2015-00299
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• 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,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: T0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2011
• 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: 72 YR