MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X440MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251440S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional 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 l22000007 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¿).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.Device is implanted.
Event or Problem Description
Sales associate opened up expired implant.Product expired may 2018.A copy of that sticker was put on the billing form.Implant was grabbed quickly and circulator was not in the room, so the sales associate opened it up at the doctor¿s request without thoroughly inspecting label.The expired device was implanted in the patient.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X440MM X 125°
• 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: 7975327
• Report Number: 0009610622-2018-01345
• Device Sequence Number: 168224
• Product Code: HSB
• UDI-Device Identifier: 07613252274322
• UDI-Public: 07613252274322
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 05/31/2018
• Device Catalogue Number: 35251440S
• Device Lot Number: K02A1D5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: 78 YR
• Patient Weight: 280