MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW; UNIT, OPERATIVE DENTAL

Catalog Number 5100131000

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

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Reported events 1 event was reported for this quarter   product return status 1 device was received for evaluation.Evaluation status 1 event was confirmed during testing.1 device was found to be affected by a missing component.Product disposition the device was repaired and 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 malfunction event in which the device had a component detach.1 event had no patient involvement; no patient impact.

• Brand Name: TPS XL OSCILLIATING SAW
• 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: 7714834
• MDR Text Key: 114939951
• Report Number: 0001811755-2018-01231
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540983930
• UDI-Public: 04546540983930
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100131000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 07/24/2018
• 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: Reuse
• Patient Sequence Number: 1