MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW MAYFIELD ADAPTOR; N/A

Catalog Number CRWMA

Device Problem Difficult To Position (1467)

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

Event Date 06/05/2016

Event Type  malfunction  

Event Description

The surgeon was unable to set the z axis target coordinate to the proper depth due to interference of the crwma mayfield adapter.The target setting was (- 62 mm) but the z axis scales bottomed out against the crwma device at -53/-54 mm.The surgeon had to reposition the patient on the or table and relocate the crwma to a position 90 degrees from his normal set up.No harm to the patient and a minimal delay of 20 minutes.This target setting is short of the available travel specified in the user's manual.Linked to mfg.Report number: 3004608878-2016-00245.

Manufacturer Narrative

Integra has completed their internal investigation on 09/19/2016.The investigation included: methods: review of device history records.Review of complaints history.Although product was not returned for investigation, a thorough review of the reported complaint was conducted.This issue was duplicated by the stereotactic sales specialist using a demo device and reviewed.The end user¿s experience was confirmed.Due to the design limitation of the crw precision arc and crwma, the target was unattainable for the type of procedure that was being performed.Device history record reviewed for this product id lot # crwp1193 manufactured on april 22, 2014 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 trackwise for this reported failure and or related to "unable to set the z axis target" for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Results: in summary, the root cause for this failure was determined to be a limitation in the design of the crwma when used with the crwprecise for the type of procedure that was being performed.

• Brand Name: CRW MAYFIELD ADAPTOR
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5947318
• MDR Text Key: 55015831
• Report Number: 3004608878-2016-00244
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2014
• 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