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

Catalog Number CRWPRECISE

Device Problem Calibration Error (1078)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the second of two reports (same device, same facility, different patients) linked to mfg report: 1222895-2016-00002.It was reported that on (b)(6) 2016 the crwprecise 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.The date of the event and the procedure being performed was unknown.There was no adverse event or adverse patient outcome reported.There was no information on what procedures were completed prior to this set up.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 20 may 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the evaluation of the returned unit found the arc to be out of calibration.The customer report of the ¿setup of the arc found it to be out of calibration¿ was confirmed.The repair technician cleaned and inspected the device.Then the unit was calibrated to manufactures' specifications free of charge.The dhr review has been deemed satisfactory.Date of manufacture: 03 nov 2014.Device history record reviewed for this product lot/serial number show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.A two year look back in (b)(6) for this reported failure and or related to "out of calibration" (calibration issue) for this product id shows that 6 complaints were received including this case, see below.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the root cause of the arc being out of calibration was not conclusively determined; no manufacturing, workmanship, or material deficiency has been identified.The crwprecise was polished, lubricated, calibrated and shipped back to the customer.

• 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: 5511782
• MDR Text Key: 41054034
• Report Number: 1222895-2016-00003
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 05/20/2016
• 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