MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31301180S

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event that trochanteric nail kit, ti gamma3® ø11x180mm x 130° was alleged of ¿ labelling - mislabelling could not be confirmed.A review of both dhrs revealed no discrepancies and both lots were documented as faultless prior to distribution.Based on image provided a cardboard box of lot code k0e2d66 [trochanteric nail kit, ti gamma3® ø11x180mm x 130°] along with a blister of lot code k098c8a could be verified.Manufacturing [label statistics as well] and distribution histories revealed, that the label of lot code k0e2d66 [catalogue #31301180s trochanteric nail kit, ti gamma3® ø11x180mm x 130°], which is present at the cardboard box was printed in january 2018 and according to stock movements the whole lot was distributed on january 31st 2018 [07 syk us; 40 syk france].The label [lot code k098c8a] which is present on the blister packaging [catalogue #31251180s trochanteric nail kit, ti gamma3® ø11x180mm x 125°] was printed in august 2018 and thus, 7 months after the product in question was already distributed.No discrepancies could be verified within the statistic for the labels.Thus, we exclude a manufacturing error resp.A mix-up at the manufacturing site.Review of stock movement revealed that both lot codes were distributed to the hospital.It is common practice to have a spare part available within the op-room during the surgical procedure.Known from a previous similar case and based on above facts it could not be excluded that it¿s rather related to a deficiency in the further treatment at hospital.

Event Description

The hospital reported the following event : "the orthopaedic intern requires a 130° short nail.The circulating ibode checks the implant, has it checked by the instrument ibo.After verification, the ibode sticks the labels and realizes that something is wrong.Indeed, she sees that the 130° nail was a 125° nail labelled and in a 130° nail package.Clinical consequences noted: none.Precautionary measures and actions taken: implant change.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
• 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: 8075478
• MDR Text Key: 129180411
• Report Number: 0009610622-2018-01400
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 04546540375124
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K034002
• 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
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 31301180S
• Device Lot Number: K0E2D66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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