MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-1242S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient came in with pain and the nail was broken at the bottom juncture of lower recon screw.Ended up removing t2 alpha retrograde nail and replacing it with a gamma nail.Surgery was successful.
Event or Problem Description
Patient came in with pain and the nail was broken at the bottom juncture of lower recon screw.Ended up removing t2 alpha retrograde nail and replacing it with a gamma nail.Surgery was successful.
Additional Manufacturer Narrative
Please note the correction to b1.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device shows misdrilling marks at the lateral entrance of the proximal through-hole around the anterior web and the center.Severe deformation (plastic deformation) was also observed on the lateral side of the proximal segment near the hole entrance for the lag screw, which indicates the shifting of the drill towards the anterior side of the nail edge resulting in chipping of metal.Due to this misdrilling, an incipient crack initiated and progressed towards the medial.Gradually, alongside the anterior web, the posterior web also started getting fatigued and broke ultimately.The fracture pattern resembles a fatigue fracture evident shiny surface on the anterior web and partial lines of rest on the initial part of the anterior web.Further a dimensional inspection reveal the nail to be within specifications.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.A few x-rays were provided which were presented to our health care professional for evaluation, and question about the most likely reason for the breakage was asked, to which medical expert replied: ¿the potential root cause for the failure is that the fracture has not healed entirely.With the new device in such a difficult location (subtrochanteric fractures tend to heal not so well) and the reduced healing capacity (due to the refracture at the same location the healing period is prolonged) the bone did not show sufficient healing again and it ended up in this breakage.I would say that patient related factors (refracture, fracture pattern (subtrochanteric)) and surgical technique (missing additional surgical measurements (like bone graft or bone marrow insertion) or an additional lateral plate to reduce the forces would have been an option) related factors led to the failure.I would not identify device related factors here.¿ [original statement(s)] based on the above investigation, the root cause was attributed to a combination of patient and user-related factors.If any further information is provided, the complaint report will be updated.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X420MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 14047849
• Report Number: 0009610622-2022-00125
• Device Sequence Number: 11989037
• Product Code: HSB
• UDI-Device Identifier: 07613327286274
• UDI-Public: 07613327286274
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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 Model Number: 2333-1242S
• Device Catalogue Number: 23331242S
• Device Lot Number: K09BF4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2018
• 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: 41 YR
• Patient Sex: Male