MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM-POOL; STEREOTAXY

Catalog Number CRWPRECISEP

Device Problems Calibration Error (1078); Out-Of-Box Failure (2311)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2016 the integra aus dc staff unpacked the crwprecise crw precision arc system from the box and set up the phantom base.All settings on the frame and phantom base were set to zero.The device had been found to be out of calibration with the point ends not meeting as desired (lateral variance to the right); it was out of tolerance 0.5mm to the right.The problem was identified at the integra aus dc and thus the device was not in contact with a patient and there was no patient injury or adverse event incident.

Manufacturer Narrative

Integra has completed their internal investigation on 17 may 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history.Results: evaluation of device: the device was received at the (b)(4) service center and staff unpacked the crwprecise from the box and set it on a phantom base (crwpbs).With all settings on the arc and phantom base set to zero, the point ends did not meet.The service technician noted a 0.5mm lateral variance to the right.The dhr review has been deemed satisfactory.Date of manufacture: oct 22 2015.Dhr show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No new design or manufacturing trends have been identified.Conclusion: in summary, the end user¿s experience was partially confirmed.Although the pointers on the crwprecise and crwpbs did not align with all settings at zero, the device setting was within ± 0.5mm or 1.0 mm total from the target setting as required.Therefore, the device was not out of calibration as noted.

• Brand Name: CRW PRECISION ARC SYSTEM-POOL
• Type of Device: STEREOTAXY
• 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: 5502403
• MDR Text Key: 40838319
• Report Number: 1222895-2016-00004
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CRWPRECISEP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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