MAUDE Adverse Event Report: STRYKER GMBH G4 LONG NAIL LEFT D10XL340MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250340S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
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 remains implanted in patient.
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2023.Because the bone was highly fragile with a strong curve, a nail of the proper length was inserted, but the nail tip protruded from the bone (and a little screw).This was discovered later when the patient was checked by ct.Revision surgery was performed on (b)(6) 2023.The screw was replaced with a condylar screw.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.However, also no evidence was provided to confirm the reported case it must be considered that within most of the cases it¿s rather clinical than device related; within the corresponding ifu it is stated ¿implant utilization that would interfere with anatomical structures or physiological performance¿ and thus, clearly pointed out under section contraindication.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.Finally, with given details no deviation of the nail in question was verified and a further technical statement could not be made.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2023.Because the bone was highly fragile with a strong curve, a nail of the proper length was inserted, but the nail tip protruded from the bone (and a little screw).This was discovered later when the patient was checked by ct.Revision surgery was performed on (b)(6) 2023.The screw was replaced with a condylar screw.".

• Brand Name: G4 LONG NAIL LEFT D10XL340MM X 125DEG
• 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: 18519623
• Report Number: 0009610622-2024-00035
• Device Sequence Number: 7773752
• Product Code: HSB
• UDI-Device Identifier: 07613327474480
• UDI-Public: 07613327474480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: Lay User/Patient
• Device Catalogue Number: 85250340S
• Device Lot Number: K13ACCD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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