MAUDE Adverse Event Report: STRYKER GMBH ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø12X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18181230S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.H3 other text : legal matter.
Event or Problem 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.

• Brand Name: ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø12X300MM
• Common Device Name: 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: 17807559
• Report Number: 0009610622-2023-00333
• Device Sequence Number: 17986965
• Product Code: HSB
• UDI-Device Identifier: 04546540202482
• UDI-Public: 04546540202482
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 18181230S
• Device Lot Number: K062F1E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 104 KG