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

Catalog Number 42250360S

Device Problem Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was not caused by a deficiency of the device as the expiry date was clearly legible on the label and the usage of the device does not lie in the responsibility of the manufacturer.The expiry date of the implanted device should have been noticed prior to surgery (refer to ifu (b)(4) in chapter sterilization/resterilization: ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier or expiration of shelf life before opening¿).Review of the device history records of the device reported did not indicate any conspicuities; the dhr contain a copy of the label set (label for packaging and patient record label).All labels indicate end of shelf life by (end of) july 2018 (nominal value).Real aging tests performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than 1 year overdue and considered still sterile subsequently.A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail (exceeded by approx.6 months) had been implanted.The expiry date is a theoretical date which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible.Nevertheless, the expiry date of the implanted device should have been noticed prior to surgery.According to available labels in the dhr the expiry date was clearly legible.Furthermore, the implant was hospital-owned at the time of implantation and it should be covered by the hospitals risk management.Thus, evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to off-label use and has to be classified as user-customer-shelf-life exceeded.Remains implanted.

Event Description

The hospital reported to the sales rep the following event : "implementation of a gamma 3 nail.Ibode noticed that the expiry date of the gamma nail had expired.The surgeon chose to implant the device anyway.

• Brand Name: LONG NAIL KIT R2.0, STST, RIGHT 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8246082
• MDR Text Key: 133201531
• Report Number: 0009610622-2019-00048
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 42250360S
• Device Lot Number: K0571CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Other