MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA TRI STAR ADAPTER ASSEMBLY; N/A

Catalog Number 41B1615

Device Problems Disconnection (1171); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Event Description

This is the first of two reports (same incident, different products).Mayfield tristar adapter (attached to the a2009 base unit) was attached to plate which was attached to the crw frame.When the doctor wanted to reposition the patient, the adaptor was unscrewed from the plate.When they went to retighten the torque screw on the adaptor, it became stuck and would not fully engage to the plate.The equipment had to be taken apart and the tristar and plate had to be replaced by using another base unit, adaptor and plate.No harm or injury to patient.Surgery delay was 45 minutes.Additional information has been requested.

Manufacturer Narrative

Additional information received on 04jan2016 from the customer: on (b)(6) 2015, a (b)(6) male underwent a deep brain stimulator lead placement.The problem with the trunnion ring occurred during positioning of the patient.The surgery was delayed about 45 minutes while a new mayfield was found and applied.There was no patient adverse consequence as a result of the surgery delay.

Manufacturer Narrative

Integra has completed their internal investigation on 02/09/2016.The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history.Results: evaluation of device: the torque knob threads are cross threaded in the crw adaptor and the torque knob handle has deep gouges on it, and needs to be replaced.The crw threaded hole insert is coming out of the adaptor.The device (b)(4) that was received and inspected was not etched with a lot# however the most likely lot # could be work order (b)(4) lot code 144 as such: device history record reviewed for product id (b)(4) work order (b)(4) lot code 144 manufactured on 04/02/2014 (qty (b)(4)) show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file.No new design or manufacturing trends have been identified.In summary: complaint confirmed as the torque knob threads are cross threaded in the crw adaptor and the torque knob handle has deep gouges on it, and needs to be replaced.The root cause could not be determined at this time.

• Brand Name: TRI STAR ADAPTER ASSEMBLY
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5340119
• MDR Text Key: 35278485
• Report Number: 3004608878-2015-00322
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41B1615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• 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: 70 YR