MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HOWMEDICA MIX KIT BOWL WITH SPATULA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 6201003410

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 1 malfunction event in which the device had unknown material in the sterile package.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device had unknown material in the sterile package.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.

• Brand Name: HOWMEDICA MIX KIT BOWL WITH SPATULA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8816015
• MDR Text Key: 152250031
• Report Number: 0001811755-2019-02369
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 34546540257803
• UDI-Public: 34546540257803
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6201003410
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1