MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø10X400MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18261040S

Device Problems Off-Label Use (1494); Expiration Date Error (2528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

The surgeon reported that he implanted a supracondylar nail into a patient which had expired in may 31st 2019.The surgeon was aware that the implant was past its expiry date at the point of implantation, but there was no alternative available.

Manufacturer Narrative

The reported event could be confirmed, since the date of implantation exceeds the date of expiry, as indicated in device history of implant.The device inspection was not possible as the product was not returned for investigation.In the event description it's mentioned that: ¿the surgeon reported that he implanted a supracondylar nail into a patient which had expired in (b)(6) 2019.The surgeon was aware that the implant was past its expiry date at the point of implantation, but there was no alternative available.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused because user did not adhere to the pre-operative instructions and ifu (instructions for use).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu states: ¿for detailed information concerning the identification of the product (such as system association, catalog no.(ref), material, expiration date of sterile products) please refer to the marking on the product and/or the labeling of the package.Pre-operative: the implant is for single use only.Ensure that all components needed for the operation are available in the operation theatre.Inspection is recommended prior to surgery to determine if instruments or implants have been damaged during storage or prior procedures." if the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The surgeon reported that he implanted a supracondylar nail into a patient which had expired in (b)(6) 2019.The surgeon was aware that the implant was past its expiry date at the point of implantation, but there was no alternative available.

• Brand Name: SUPRACONDYLAR NAIL T2 SCN Ø10X400MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8837921
• MDR Text Key: 153274534
• Report Number: 0009610622-2019-00575
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K023267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 18261040S
• Device Lot Number: K098BF3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR