MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 43250360S

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device is not cleared in the us, however similar devices are cleared in the us. Upon completion of investigation, additional information will be provided in a supplemental report. Device remains implanted; packaging will be evaluated.

Event Description

Customer reported that : "i wanted to inform you of a quality defect found on the packaging of a gamma 3 nail. When using the nail, some of the white packaging foam remained on the device. [. ] the implant was used after cleaning. ".

• Brand Name: LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X360MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9808948
• MDR Text Key: 191550127
• Report Number: 0009610622-2020-00095
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 43250360S
• Device Lot Number: KU71783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial