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

Catalog Number CRWPRECISE

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation completed 11/16/2017. Device history record reviewed for product id crwprecise, serial # (b)(4) was manufactured on 08feb15 with no abnormalities related to the reported failure. The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework. There is no service history for this device. A two year look back from 11/02/2015 to 11/02/2017 for this reported failure and or related to "frame slipped" for product id's crwprecise shows no other prior complaints were received; no new design or manufacturing trends have been identified. One crwprecise crw precision arc system was received at the (b)(4) service centre in october-2017. The device was received without the lateral slide lock. Crw trunnions were found to lock as intended. The trunion components (shafts, knobs, and rings) were within specification. Resolution: the device is being shipped back to the customer, in same condition as it was received. The customer is advised to tighten both the thumb screws on the trunnions after tightening both the trunion rings. The reported failure mode was not duplicated, the complaint is unconfirmed.

Event Description

It was reported that the frame was not locking when tightened and slipping during the case. The territory manager is following up with the customer for patient related information. No patient injury has been reported in the information received so far. The device has been recently returned to the customer after annual calibration. This was the first case after calibration.

• 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: 7032453
• MDR Text Key: 249110390
• Report Number: 3004608878-2017-00312
• 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

• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown