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

Model Number 5100015270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received.Event confirmation status: 1 reported event was confirmed.1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a separated nose tip and missing components.1 device had no problem found.2 devices were not labeled for single-use.2 devices were not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events in which the device had a component detach.2 events had no 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: 10748424
• MDR Text Key: 213455498
• Report Number: 0001811755-2020-02852
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 04546540380289
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5100015270
• Device Catalogue Number: 5100015270
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• 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