MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE FEMUR ANTEGRADE IMN INSTRUMENTS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-3105

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "it was difficult to remove the drill sleeve that had been inserted into the adjusting device of the distal target device. The lock mechanism was stiff, blood was clogged and the lock was stiff. Please check if there are any defects in the adjusting device itself. " additional information: according to the report, the blood was clots and lock mechanism was hard. No medical intervention measures were needed.

• Brand Name: ADJUSTING DEVICE FEMUR ANTEGRADE IMN INSTRUMENTS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11373086
• MDR Text Key: 233335795
• Report Number: 0009610622-2021-00292
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2353-3105
• Device Catalogue Number: 23533105
• Device Lot Number: KME914877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse