MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X440MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-1144S
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	12/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; disposed by hospital.
Event or Problem Description
As reported, "nail and screw breakage of alpha gt femoral nail.Patient was referred from er with broken hardware around nonunion site of a former proximal femoral fracture.Surgery was performed to remove hardware and replace in order to achieve union.".
Event or Problem Description
As reported, "nail and screw breakage of alpha gt femoral nail.Patient was referred from er with broken hardware around nonunion site of a former proximal femoral fracture.Surgery was performed to remove hardware and replace in order to achieve union.".
Additional Manufacturer Narrative
The reported event could be confirmed, based on x-rays provided, only, a broken nail could be verified.According to event details given within product inquiry the item was removed on (b)(6) 2022 ¿¿removed on (b)(6) and replaced with smith and nephew metatan¿ which is a hint to insufficient bone healing after an implantation duration of approximately 7 months.Furthermore, a non-union, confirmed by hcp, and diabetes were reported.Finally, it is unknown which post-operative weight-bearing behavior instructions were given by the surgeon and if the patient was compliant to this.Images available were forwarded to a medical expert for review and further statement ¿ excerpts: ¿¿despite momentum (distal screw fractured), the very oblique and unfavorably sub trochanteric fracture gap has not healed.This shows hypertrophic callus formation around the fracture¿¿ the question if this could be in correlation with the reported diabetes was stated as following: ¿could certainly be a reason.So this as a patient-specific.On the other hand, the broken screw shows that dynamic locking would probably have been appropriate here-although with the risk that the fracture ends slipped past each other, so to speak.There is a relatively large amount of space in the proximal portion, which also prevented compression in the joint space.Perhaps a cerclage would have helped proximally, but this could only be well assessed with an immediate postoperative image¿¿ one requirement for successful nail treatment is a timely bone healing in order to relieve the implant[s] over the progressing time of implantation.Potential adverse effects are clearly pointed out in the labelling.Nevertheless, based on the information given an exact root cause of the reported event could not be determined and a thorough technical statement was impossible, but it could not be excluded that it is rather related to patient conditions [non-union/ diabetes] and thus, classified as patient-patient factors issue.A review of the device history was not possible because the lot number was not communicated.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 substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X440MM
• 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: 16225506
• Report Number: 0009610622-2023-00015
• Device Sequence Number: 5490168
• Product Code: HSB
• UDI-Device Identifier: 07613327286595
• UDI-Public: 07613327286595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Model Number: 2333-1144S
• Device Catalogue Number: 23331144S
• Device Lot Number: K0E82E6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 165 KG