MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1832-1035S

Device Problem Material Twisted/Bent (2981)

Patient Problems Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Implant Pain (4561)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pain, restricted range of motion (rom) due to failure of fixation with recurrent varus deformity, and slipping out of the proximal interlocking screw could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device not available.

Event Description

The manufacturer became aware of a literature published by the ¿department of (b)(6) center, (b)(6) hospital, (b)(6)¿.The title of this report is, ¿evaluation of intramedullary nail fixation via the neviaser portal for proximal humerus fracture¿ published on february 08, 2019, which is associated with the stryker ¿t2 proximal humeral nailing system¿.The article can be found at https://doi.Org/10.1016/j.Jcot.2019.02.007.This report includes an analysis of the clinical data that was collected on 4 patients.The cases in this study range from april 2014 and march 2017.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced pain, and restricted range of motion (rom) due to failure of fixation with recurrent varus deformity and slipping out of the proximal interlocking screw.The report states, ¿in this case, we used a bent nail unlike the other three cases in which straight nails were used.We consider this difference can be a cause of this complication.This patient also experienced failure of fixation with recurrent varus deformity and slipping out of the proximal interlocking screw at 6 weeks postoperatively.However, she remained under observation, because her pain was within the manageable limit, and finally, she was able to achieve bone-union without any exacerbation of her symptoms.Although active rom of her affected shoulder was restricted and moderate pain was still experienced during the shoulder motion, she was able to use her affected arm to perform daily living activities.¿.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic hand and microsurgery center, osaka ekisaikai hospital, japan¿.The title of this report is, ¿evaluation of intramedullary nail fixation via the neviaser portal for proximal humerus fracture¿ published on february 08, 2019, which is associated with the stryker ¿t2 proximal humeral nailing system¿.The article can be found at https://doi.Org/10.1016/j.Jcot.2019.02.007.This report includes an analysis of the clinical data that was collected on 4 patients.The cases in this study range from april 2014 and march 2017.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced pain, and restricted range of motion (rom) due to failure of fixation with recurrent varus deformity and slipping out of the proximal interlocking screw.The report states, ¿in this case, we used a bent nail unlike the other three cases in which straight nails were used.We consider this difference can be a cause of this complication.This patient also experienced failure of fixation with recurrent varus deformity and slipping out of the proximal interlocking screw at 6 weeks postoperatively.However, she remained under observation, because her pain was within the manageable limit, and finally, she was able to achieve bone-union without any exacerbation of her symptoms.Although active rom of her affected shoulder was restricted and moderate pain was still experienced during the shoulder motion, she was able to use her affected arm to perform daily living activities ¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The alleged event could be confirmed, with the available radiographs in the literature.From the available radiographs, a formal medical opinion sought states: "that the approach used in surgery is not the one recommended in the op-tech for stryker t2 humeral nails.However, apart from this, such an indication can be treated with this nail.The nail in the x-ray seems to protrude beyond the cortex which may lead to a conflict with the acromion or the rotator cuff and result in reduced mobility.The issues may be related to the device, but it is more likely, that the complications that occurred are related to the procedure, from the x-ray it looks like the nail has not been positioned at the lateral center which would be necessary for a bent nail.The authors emphasize that it is possible, that this could be a general problem with the chosen entry point/portal/approach.Then it would be assessed as a procedure-related issue.With the available patient history, we learn, however, that there have been problems with moving already before the operation, making the insertion of the nail less likely to be the root cause of the described event.The proximal screws are backed out clearly.The nail stayed in place in the shaft part of the humerus, but it is possible, that the head dislocated slightly, when the fixation due to the backing out of the screws loosened.The dislocation and migration of the screws are far better visible than that of the nail".Based on the investigation and formal opinion, the root cause was attributed to off-label use.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14610035
• MDR Text Key: 293437868
• Report Number: 0009610622-2022-00223
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540515414
• UDI-Public: 04546540515414
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: 1832-1035S
• Device Catalogue Number: 18321035S
• Device Lot Number: K07C7BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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 Sex: Female