MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø10X380 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18511038S

Device Problem Expiration Date Error (2528)

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

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted.

Event Description

Doctor implanted a gtn nail.Implant after about 3/4 of the way down (almost seated) it was noticed that it was expired ((b)(6) 2016).Package was not compromised.Doctor opted to leave implant in rather than exchange it.

Manufacturer Narrative

Referring to the product inquiry the femoral nail, right t2 gtn ø10x380 mm is the only reported device and thus considered the primary product.The nail reported remains implanted.The issue is about an exceeded expiry date 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 feb 29, 2016 (nominal value).The device reported was documented faultless prior to distribution.In the case presented a t2 greater trochanter nail (t2 gtn) was implanted whose sterilization date was exceeded by 42 days (expiration date: 02/29/2016; date of implantation: (b)(6) 2016).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.Thus, in this specific case of exceeded expiry date by 42 days a risk for the patient is not to be expected.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.Nevertheless, the expiry date of the reported nail kit should have been noticed prior to surgery as it is always to be noticed on the label; according to the sales rep the implant was hospital-owned at the time of implantation.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to misuse; the root cause of the event is in the field of responsibility of the user.No non-conformity in terms of product quality was identified.

Event Description

Doctor implanted a gtn nail.Implant after about 3/4 of the way down (almost seated) it was noticed that it was expired ((b)(6) 2016).Package was not compromised.Doctor opted to leave implant in rather than exchange it.

• Brand Name: FEMORAL NAIL, RIGHT T2 GTN Ø10X380 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: 5640408
• MDR Text Key: 45092984
• Report Number: 0009610622-2016-00245
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 18511038S
• Device Lot Number: K915825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2011
• 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: 25 YR
• Patient Weight: 64