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

Catalog Number CRWPRECISE

Device Problems Calibration Error (1078); Calibration Problem (2890)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2016

Event Type  malfunction  

Event Description

This is the first of two reports (same device, same facility, different patients).Linked to mfg report: 1222895-2016-00003.It was reported that on (b)(6) 2016 the crw precise crw precision arc system was set up and found to be out of calibration by approximately 0.3mm.The arc device was not in contact with the patient since it was not used after completing the set up.There was no adverse event or adverse patient outcome reported.There was no information on what procedure the set up was for or what procedures were completed prior.There was no report of any delay in surgery due to the product problem.The arc was used by the surgeon twice and the calibration was not correct both times.

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.The device has been cleaned and inspected.The returned device was calibrated to manufacturers' specification.The dhr review has been deemed satisfactory.Date of manufacture: nov 03 2014.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, no root cause can be determined at this time however, this issue will be monitored.

• Brand Name: CRW PRECISION ARC SYSTEM
• 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: 5493613
• MDR Text Key: 40421651
• Report Number: 1222895-2016-00002
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• 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