MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FEMORAL CANAL TIP, IRRIGATION/SUCTION; LAVAGE, JET

Catalog Number 0210008000

Device Problem Fracture (1260)

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

Event Date 09/30/2022

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 not available for evaluation.Additional information: 2 devices were labeled for single-use.2 devices were reprocessed or reused.Device not available.

Event Description

This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.

Manufacturer Narrative

Correction: corrected data: h10.Additional information: 2 devices were not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.

• Brand Name: FEMORAL CANAL TIP, IRRIGATION/SUCTION
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; highway #3, km 130.2; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15666568
• MDR Text Key: 306799880
• Report Number: 3015967359-2022-02077
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540144158
• UDI-Public: 34546540144158
• 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,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0210008000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1