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

Catalog Number CRWPRECISE

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported that a brand new crw precision frame was used for the first case and the trunnion rings got stuck.After taking ct scan and the patient was on the table, the arc didn¿t move.They tried to open the "ln screw" and they were still unable to rotate the arc.Surgery was canceled.Additional information has been requested.Linked to mfg.Report number: 3004608878-2017-00094.

Manufacturer Narrative

Investigation completed 5/05/17.Method: trend analysis.A two year look back for this reported failure and or related to "trunnion rings are sticking or is completely stuck" for this product id shows that 28 complaints were received including this case.Capa has been issued to further investigate this reported failure.The defect described in this complaint was confirmed; in both of the swivel adapters there are lateral cracks around the radius of the inner diameter hole.Since the cracks were discovered during the distributor¿s inspection and these units had not been placed in service, would indicate the cracks were present during the final quality inspection before release.Reviewed the completed 1101 form from dec 12, 2016 and the inspector did not note any nonconformance.Conclusion: failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation and three attempts have been made.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6463244
• MDR Text Key: 72446591
• Report Number: 3004608878-2017-00093
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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