MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X80 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965080S

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.

Event Description

It was reported that the doctor put a nail in to help a broken tibia and 8-10 days later patient went in and had the staples taken out and was bandaged up.A few hours (3-4) after returning home the patient noticed blood around the bandaged area and the screw backing out.Patient called the doctor and was advised to go the er.Screw was removed when patient went to the er.Screw protruding from left side ankle.Ed recommended wearing a non-weight bearing boot.Pt was provided a prescription for antibiotics.

Manufacturer Narrative

The reported event could be confirmed, from the pictures provided for evaluation and matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Few x-rays were presenting no implanted screw and few pictures of partially back out screw and completely removed screw was provided which were presented to our health care professional for evaluation, and a question about the most likely reason for this event, to which the medical expert replied: due to lack of good quality x-rays and with the limited available pictures we cannot say what happened here.There is no picture where the final construct is shown in 2 or more directions.Based on the information provided the exact root cause could not be determined.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 device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the doctor put a nail in to help a broken tibia and 8-10 days later patient went in and had the staples taken out and was bandaged up.A few hours (3-4) after returning home the patient noticed blood around the bandaged area and the screw backing out.Patient called the doctor and was advised to go the er.Screw was removed when patient went to the er.Screw protruding from left side ankle.Ed recommended wearing a non-weight bearing boot.Pt was provided a prescription for antibiotics.

Event Description

It was reported that the doctor put a nail in to help a broken tibia and 8-10 days later patient went in and had the staples taken out and was bandaged up.A few hours (3-4) after returning home the patient noticed blood around the bandaged area and the screw backing out.Patient called the doctor and was advised to go the er.Screw was removed when patient went to the er.Screw protruding from left side ankle.Ed recommended wearing a non-weight bearing boot.Pt was provided a prescription for antibiotics.

Manufacturer Narrative

Please note the corrections to d1, d4 catalog #, d4 lot #, h6 device and h6 method codes.The reported event could be confirmed, from the pictures provided for evaluation and matches the alleged failure mode.The device inspection was not possible since the affected device was not returned but pictures were provided which confirms screw back out.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.Few x-rays were presenting no implanted screw and few pictures of partially backout screw and completely removed screw was provided which were presented to our health care professional for evaluation, and a question about the most likely reason for this event, to which the medical expert replied: due to lack of good quality x-rays and with the limited available pictures we cannot say what happened here.There is no picture where the final construct is shown in 2 or more directions.Based on the information provided the exact root cause could not be determined.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 device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X80 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 17010922
• MDR Text Key: 316023538
• Report Number: 0009610622-2023-00176
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202574
• UDI-Public: 04546540202574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965080S
• Device Lot Number: K0D3B03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: 104 KG