MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965035S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "after the initial surgery, the fracture became pseudoarticular and the nail eventually broke off.After removal, it was replaced with tha.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and is indeed broken.The device inspection revealed the following: the returned devices in the scope of this pi show indeed the broken nail, as well as a broken distal screw.The product identification of the broken devices could be confirmed.The broken distal screw was also analyzed.The broken surface also shows rest lines, specific to fatigue fractures.Therefore, it can be concluded that the screw too, broke in a fatigue manner.Since x-rays were provided, a medical expert's opinion on this case was requested.Their statement is as follows: "a pseusoarthrosis is another word for non union.So based on the story this is a clear non-union case with in the end nail breakage.[.] [based on the pictures] clearly the fracture did not fully heal.This is not the image you expect after 3 years of healing" based on investigation, the root cause was attributed to mostly a patient related issue.The event was caused by the non union of the bone, which caused excessive loads on the nail for an extended amount of time (3 years) before the device finally broke in a fatigue manner.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM
• 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: 18090438
• Report Number: 0009610622-2023-00395
• Device Sequence Number: 5992939
• Product Code: HSB
• UDI-Device Identifier: 04546540202482
• UDI-Public: 04546540202482
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: 10/31/2024
• Device Catalogue Number: 18965035S
• Device Lot Number: K081E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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 Sex: Female