MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X65 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965065S

Device Problem Device Expiration Issue (1216)

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

Event Date 01/13/2016

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

Our customer informed us that 2 expired devices have been implanted in the first days of (b)(6).

Manufacturer Narrative

Referring to the product inquiry both the nail and the screw are stated to be products in question.No further associated products were reported.The devices reported remain implanted.The issue is about exceeded expiry dates and physical examination is not required.Review of the device history records of the nail reported did not indicate any conspicuity.The dhr contain a copy of the label set (label for packaging and patient record label); all labels indicate end of shelf life by nov 30, 2015 (nominal value).The device reported was documented faultless prior to distribution.Review of the device history records of the screw reported did not indicate any conspicuity.The dhr contain a copy of the label set (label for packaging and patient record label); all labels indicate end of shelf life by dec 31, 2015 (nominal value).The device reported was documented faultless prior to distribution.In the case presented two apparently expired products were implanted, which is considered off-label use.The expiry date is always to be noticed on the label of each sterile product.In case of the nail the sterility expiration date was exceeded by 36 days (expiry date on label: nov 30, 2015; date of surgery: (b)(6) 2016).In case of the screw the sterility expiration date was exceeded by 5 days (expiry date on label: dec 31, 2015; date of surgery: (b)(6) 2016).Since the products were on consignment at the time of implantation, the distribution center is responsible for the exceeded expiry dates which should have been noticed prior to surgery.Thus, local capa # (b)(4) was initiated at the italian distribution site which has triggered following actions according to information received: immediate training to the operators (trainer kit room manager).It was elaborated a draft work instruction about the management of the expire date of products contained in sterile kits.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 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.Evaluation revealed evidence that the event is not linked to a deficiency of the devices but is rather related to off-label use (error on part of the distribution center).No non-conformity in terms of product quality was identified.

Event Description

Our customer informed us that 2 expired devices have been implanted in the first days of (b)(6).

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X65 MM
• 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: 5412762
• MDR Text Key: 38106933
• Report Number: 0009610622-2016-00047
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K032244
• 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,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 18965065S
• Device Lot Number: K445057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2010
• 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
• Patient Age: 75 YR