MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-1034S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	11/28/2022
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.Device disposition unknown.
Event or Problem Description
It was reported that the nail was broken at the distal lag screw hole.It was an unstable case due to an atypical femoral fracture, and it took a long time for the bone fusion.The revision surgery was planned for (b)(6) 2022 with long gamma nail or t2 alpha gt nail.Any plate might be added.
Additional Manufacturer Narrative
Please note correction to d4 (lot #).The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail was completely broken at proximal.The breakage surfaces of the thinned webs of the distal recon lag screw hole, proximally to the oblong hole, showed clear evidences of a fatigue fracture ¿ indicated by lines of rest progressing from lateral towards medial, missing plastic deformation and a residual fracture, in ductile manner, at medial.The superior edge of the same drill hole had become damaged intra-operatively by a drill.Chamfer-like material abrasion progressed into the breakage line where the initial incipient crack was found to be in the anterior web at lateral.Removed material had weakened the material significantly.Dimensional inspection indicates that the device is within the specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.In the case presented a 72 year-old female patient, no data provided, had been treated with above implant on an unknown date for an unknown reason.Allegedly on (b)(6) 2022 the implant was revised due to breakage.Except of an undated x-ray copy no medical records were made available.The fracture pattern of the returned nail fragments clearly identified a fatigue fracture.The incipient crack had started in the distal drill hole for the lag screw at lateral where material had been removed by drill contact.This damage had weakened the material's durability significantly.With 1 undated x-ray, only a medical review was classified not being justified.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.Received information revealed it was an unstable case, and it took a long time for the bone fusion.1 undated x-ray in p-p-view showed the broken nail and a trochanteric bone fragment completely broken at the lesser trochanteric region.Summarizing above,, the root cause was classified as user related, contributed by patient's condition.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the nail was broken at the distal lag screw hole.It was an unstable case due to an atypical femoral fracture, and it took a long time for the bone fusion.The revision surgery was planned for (b)(6) 2022 with long gamma nail or t2 alpha gt nail.Any plate might be added.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X340MM
• 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: 16010793
• Report Number: 0009610622-2022-00592
• Device Sequence Number: 12618996
• Product Code: HSB
• UDI-Device Identifier: 07613327285901
• UDI-Public: 07613327285901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 04/18/2023

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: 2333-1034S
• Device Catalogue Number: 23331034S
• Device Lot Number: K097D00
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• 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: 72 YR
• Patient Sex: Female