MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, RECON T2 RECON 6.5X110 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1897-6110S

Device Problem Malposition of Device (2616)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The customer reported: "absence of locking of the cervicocephalic screws in the nail".Update 08/06/2020: sales rep reported: "so i met the surgeon today.This is a t2 recon nail and 2019 and 2 cervical screws placed on (b)(6).The intervention went well without any delay in the installation of the material.During the post-op control the nail looks well placed.On the other hand, the surgeon noticed on the control x-rays at 3 months that the cervical screws were not inserted inside the nail but outside it.He did a material vigilance on the fact that the target device had aimed next to it and isolated the implants (1 nail, 2 cervical screws).He took the patient back on (b)(6) 2019 with a long gamma 3 nail and the patient is now solid." update 09/06/2020: according to the sales manager "the screws were never inside the nail, this is a mistake of aiming and a bad radiographic control during the intraoperative period.".

Event Description

The customer reported: "absence of locking of the cervicocephalic screws in the nail".Update 08/06/2020.Sales rep reported: "so i met the surgeon today.This is a t2 recon nail and 2019 and 2 cervical screws placed on august 28.The intervention went well without any delay in the installation of the material.During the post-op control the nail looks well placed.On the other hand, the surgeon noticed on the control x-rays at 3 months that the cervical screws were not inserted inside the nail but outside it.He did a material vigilance on the fact that the target device had aimed next to it and isolated the implants (1 nail, 2 cervical screws).He took the patient back on (b)(6) 2019 with a long gamma 3 nail and the patient is now solid." update 09/06/2020.According to the sales manager "the screws were never inside the nail, this is a mistake of aiming and a bad radiographic control during the intraoperative period.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.We received a sequence of undated x-ray images.For a thorough and comprehensive medical statement of an medical expert images of good quality in a-p and m-l view as well are needed.A device inspection of the lag screw was not possible since the affected device was not returned.The returned nail shows clear signs of a deviated step drill at the proximal bore holes of the nail and drilling marks at the distal end as well.A pre-surgical function test was performed on the nail returned.Therefore, the implant was checked with sample instruments.The drills passed the proximal drill bores of the nail with no contact.An alleged inaccuracy of positioning within the nail [alleged mis-targeting] could not be reproduced.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Although a root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: LAG SCREW, RECON T2 RECON 6.5X110 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; GM D-24232
• MDR Report Key: 10218221
• MDR Text Key: 197155075
• Report Number: 0009610622-2020-00308
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540384829
• UDI-Public: 04546540384829
• Combination Product (y/n): N
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1897-6110S
• Device Catalogue Number: 18976110S
• Device Lot Number: K07F8C2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 70