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

Catalog Number 5100131000

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 event was reported for this quarter.1 device was received for evaluation; 1 event was confirmed.1 device was found to be affected by disassembly after components migrated in the device.The device was found to have non-stryker repairs.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes malfunction event in which the device disassembled.1 reported event had no patient involvement; no patient impact.(b)(4).

• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219402
• MDR Text Key: 98434578
• Report Number: 0001811755-2018-00125
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• 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
• Date Manufacturer Received: 09/02/2017
• 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: Reuse
• Patient Sequence Number: 1