MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

Catalog Number 5100015270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Reported events : 8 events were reported for this quarter  . Product return status : 8 devices were received for evaluation. Evaluation status : 5 events were confirmed during testing, - 5 devices were found to be affected by detached/missing components, 3 device evaluations are in progress. Product disposition : these devices are not repairable and were not returned to the user facility.          additional information : there were no remedial actions taken on this device. This device is not labeled for single-use.

Event Description

This report summarizes 8 malfunction events in which the device had a component detach; 7 events had no patient involvement; no patient impact; 1 event had patient involvement; no patient impact.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7714820
• MDR Text Key: 115213959
• Report Number: 0001811755-2018-01223
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 8
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5100015270
• Device Lot Number: E2015055
• 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: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse