MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; BASE UNITS AND ADAPTERS

Catalog Number A2009

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

It was reported that the device broke; the head clamp had fallen apart.It happened just before the use had connected it to the patient's head.There was surgery delay due to this failure.Additional information has been requested.

Manufacturer Narrative

Additional information received on (b)(6) 2015: the issue occurred on (b)(6) 2015 when they tried to close the handle before attaching the head to the clamp.The (b)(6) year old male patient was already under anesthesia when the dysfunction occurred.The event led to an increase in surgery time; time needed to change to another mayfield.There was no harm to the patient.

Manufacturer Narrative

Integra has completed their internal investigation on 1/19/2016.The investigation included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: evaluation of device: only the lower base handle has been sent in for evaluation.The ¿long cam rod 41a1654¿ has snapped off causing the unit to come apart.The reported breakage on this particular cam rod occurred at the threaded area.Cam rod¿s thread passed the go and no go plug gage (st-225) inspection and its minor diameter was also inspected on the optical comparator (c-300) and was found within range.The bore sizes could not be measured as these were slotted/assembled during the previous service.This device passed all required inspection points with no associated mrr¿s, or variances.This base handle was serviced as part of the recall action item in (b)(4) in mar2015.A review of complaints history for similar "cam rod fracture" revealed 17 complaints have been received including case.Conclusion: engineering and repairs were able to verify the customer complaint; however, the root cause cannot be determined as the reported breakage occurred at the threaded area of the cam rod.Additionally, the entire unit was not returned to cincinnati for evaluation presenting a limiting factor for this complaint report.Capa has been initiated to address this issue.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Type of Device: BASE UNITS AND ADAPTERS
• 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: 5279168
• MDR Text Key: 33477644
• Report Number: 3004608878-2015-00302
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2009
• Device Lot Number: 127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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: 55 YR