MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, COMPRESSION S2 Ø11X390 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	17251139S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
Event or Problem Description
The pharmacist from the hospital reported the following event: "expired tibial nail s2 was implanted in (b)(6) 2018.
Event or Problem Description
The pharmacist from the hospital reported the following event: "expired tibial nail s2 was implanted in (b)(6) 2018.
Additional Manufacturer Narrative
The reported event that tibial nail, compression s2 ø11x390 mm was alleged of 'sterile period expired' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the dhr revealed no discrepancies, in particular in the labelling process.The device reported was documented as faultless prior to distribution.All labels indicate end of shelf life by june 2018.In the case presented an apparent expired tibial nail was implanted which is beyond the manufacturer¿s control.The sterility expiration date was exceeded by approx.3 months (expiry date on label: june 2018; date event occured: (b)(6) 2018).Thus, the event does not present a manufacturing and/or labelling issue.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 medical consultation in a similar case (a nail has been implanted approx.6 months after expiry date) revealed that any such situation does not require medical intervention and a risk for the patient is not to be expected.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.Based on the above the event is not linked to a deficiency of the device but is rather related to off-label use.

• Brand Name: TIBIAL NAIL, COMPRESSION S2 Ø11X390 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7924064
• Report Number: 0009610622-2018-01342
• Device Sequence Number: 11339156
• Product Code: HSB
• UDI-Device Identifier: 04546540396433
• UDI-Public: 04546540396433
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 17251139S
• Device Lot Number: K04DC82
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Weight: 117