MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA? TIBIA Ø9X330MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23410933S
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	08/16/2023
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 discarded by user.
Event or Problem Description
It was reported that the patient showed up at clinic and had a broken nail, which was discovered when the x-rays were taken.Patient initially suffered from severe open wound fracture requiring external fixator, following implantation of plate and screws.It was also reported that the patient was revised due to infection in (b)(6) 2023; the event was reported under separate complaint.
Additional Manufacturer Narrative
The reported event could be confirmed based on x-ray images provided, only, which present a broken nail.A technical statement could not be given as the item was not made available for inspection [discarded by facility] and thus, a physical inspection impossible due to missing item and evaluation limited to x-ray images provided.The labelling points out that for successful results a timely bone healing is required; this state must be achieved within a medically recognized period [confirmed by scientific analysis about 6 months] in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.Furthermore, delayed union or non-union of the fracture site are clearly pointed out as adverse effects and may be rather clinical than device related.Nevertheless, all three [3] x-ray images, provided for the current reported event, were forwarded to a medical expert for review and statement ¿ excerpts: ¿¿looking at the current x-rays there is an evident non-union in the distal tibia and in the fibula, which exist for a while looking at the rounded edges of the bone fragments.A (low-grade) infection may still be present, but that cannot be confirmed with these x-rays.The location of the existing non-union, the choice of the implant given that location, and the patient activity levels post-op may all have contributed to an inadequate load distribution, and therefore the breakage of the implant.A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient.Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.The patient should go, for a second opinion, to another surgeon if they want to obtain advice on the current treatment and possible treatment options for the future.¿ with given information no deficiency of the nail in question was verified.Based on current information provided and referring to hcp statement the case is rather related to patient factors.Finally, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.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.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
It was reported that the patient showed up at clinic and had a broken nail, which was discovered when the x-rays were taken.Patient initially suffered from severe open wound fracture requiring external fixator, following implantation of plate and screws.It was also reported that the patient was revised due to infection in (b)(6) 2023; the event was reported under separate complaint.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø9X330MM
• 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: 17724180
• Report Number: 0009610622-2023-00309
• Device Sequence Number: 7213177
• Product Code: HSB
• UDI-Device Identifier: 07613327290745
• UDI-Public: 07613327290745
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Catalogue Number: 23410933S
• Device Lot Number: K0474CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 127 KG