MAUDE Adverse Event Report: NORTHERN DIGITAL INC. NDI PASSIVE MARKER SPHERES REFLECTIVE PASSIVE MARKER SPHERES

Model Number 8801071

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

Device discarded by site.

Event Description

Clinical specialist reported that during a hip replacement case while reaming, the spheres would come off. There was a minimal delay in the case while getting new spheres. Spheres were discarded by site. No lot number information was recorded by site. This occured at (b)(6) hospital. Customer reported no serious injury/death to patient or users.

• Brand Name: NDI PASSIVE MARKER SPHERES
• Type of Device: REFLECTIVE PASSIVE MARKER SPHERES
• Manufacturer (Section D): NORTHERN DIGITAL INC.; 103 randall drive; waterloo, ontario N2V 1 C5; CA N2V 1C5
• Manufacturer (Section G): IIMAK MEXICANA S. DE R.L. DE C.V.; brecha e99 l15e; parque industrial reynosa; reynosa tam, CP887 80; MX CP88780
• Manufacturer Contact: gord wehner ; 103 randall drive; waterloo, ontario N2V 1-C5 ; CA N2V 1C5 ; 8845142
• MDR Report Key: 5431917
• MDR Text Key: 38702680
• Report Number: 3002743211-2016-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/31/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8801071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage