MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X30MM; SCREW, FIXATION, BONE

Catalog Number	23615030S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "bone fracture occurred along the advanced locking screw insertion position.Screw insertion was performed after 4.2mm drill followed counterbore drilling.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
Please note the correction to h6 method codes.The reported event could be confirmed from the available radiograph.With the available radiograph, a formal medical opinion was sought: "with the provided limited information complete assessment cannot be provided.With available patient details age and weight, it can be considered that the patient is frail.With age, there is very likely presence of severe osteoporosis.The nail seems to be relatively big and short.Reaming might have made the cortex so thin that either the reaming itself, the nail insertion, or the drilling of the screws caused the frail bone to fracture further.With the patient's conditions, it is a challenge to treat their fractures.".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.Based on the available information a definite root cause cannot be provided but most probably the root cause can be a combination of patient and user-related factors.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "bone fracture occurred along the advanced locking screw insertion position.Screw insertion was performed after 4.2mm drill followed counterbore drilling.".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X30MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18065669
• Report Number: 0009610622-2023-00387
• Device Sequence Number: 20731440
• Product Code: HWC
• UDI-Device Identifier: 07613327381498
• UDI-Public: 07613327381498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23615030S
• Device Lot Number: K03A95E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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
• Patient Weight: 37 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian