MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1896-5050S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 02/27/2022

Event Type  Injury  

Event Description

As reported: "the patient underwent emergency surgery on (b)(6) 2022 and returned to the emergency room on (b)(6) 2022 presenting pain and difficulty in locomotion in which after x-ray it was evidenced that the distal screw was broken.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the patient underwent emergency surgery on (b)(6) 2022 and returned to the emergency room on (b)(6) 2022 presenting pain and difficulty in locomotion in which after x-ray it was evidenced that the distal screw was broken.".

Manufacturer Narrative

The device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If the device is returned or any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

Manufacturer Narrative

Correction: please refer to d9/h3-the product was returned, h6 component, method, results & conclusion codes.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was found to be broken from the mid-shaft region.A few threads were found to be deformed around the nail contact region, indicating towards a high compressive load.The fracture pattern resembles a fatigue fracture evident by the shiny and clean surface and partial lines of rest on the initial part due to high cyclic loading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.An x-ray was provided which was presented to our health care professional for evaluation, and a question about the most likely reason for the breakage was asked, to which the medical expert replied: ¿in this case, it would be helpful to have a further x-ray showing the fracture site as well.It is likely that the breakage occurred due to some self-dynamization of the nail because of persisting fracture gap after the insertion of the nail, but that can only be said with confidence with the x-ray.¿ [original statement(s)] based on the above investigation and available information, the root cause of the failure is deemed to be more likely patient-related.The early breakage and deformed thread indicate towards overloading of the screw.The overloading is most likely due to the excessive weight of the patient as indicated in the details.If any additional information is received, the record will be updated.

Event Description

As reported: "the patient underwent emergency surgery on (b)(6) 22 and returned to the emergency room on (b)(6) 22 presenting pain and difficulty in locomotion in which after x-ray it was evidenced that the distal screw was broken.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 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: 13951405
• MDR Text Key: 288210710
• Report Number: 0009610622-2022-00109
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K203819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1896-5050S
• Device Catalogue Number: 18965050S
• Device Lot Number: K0B8661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 110 KG