MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PHANTOM BASE ASSEMBLY; N/A

Catalog Number CRWPBS

Device Problems Out-Of-Box Failure (2311); Failure to Calibrate (2440); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Event Description

A complaint was received for the crwpbs phantom base assembly stating the unit was un-calibrated.The unit was purchased by the customer in (b)(6) 2016.The event occurred on (b)(6) 2016 with the integra sales rep present during set up prior to first clinical use.It was considered to be an out of box failure.The crw precision system was set up on the phantom base, for the customer, with co-ordinates.The frame was found to be un-calibrated with the point ends not meeting.All settings on the frame and phantom base were set to zero yet the result was off by about 2mm.The device was not in contact with a patient and no patient injury or adverse event occurred.

Manufacturer Narrative

Integra has completed their internal investigation on 20 may 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: device was returned to the (b)(6) authorized repair center.Device has been cleaned and inspected.Unit received with notes ¿¿frame has been found to be with the point ends not meeting.¿ the returned device was found to measure 0.5mm when set up on the calibration base in the (b)(6) service centre.Additional investigation by ils (b)(4) and ils (b)(4) shows that the returned device is within the allowable specification of +/- of 0.5mm.The dhr review has been deemed satisfactory.Date of manufacture: 06 nov 2015.Device history record reviewed for this product show no abnormalities related to the reported failure.No abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this lot/work order number.No new design or manufacturing trends have been identified.Conclusion: in summary, no root cause can be determined at this time, however, this issue will be monitored.

• Brand Name: PHANTOM BASE 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5600264
• MDR Text Key: 44207644
• Report Number: 3004608878-2016-00090
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CRWPBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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