MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-0930S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "after the surgery, the patient came to the hospital complaining of pain in the lower limbs, and an examination revealed a deformity of the nail.Revision surgery with plates is scheduled for (b)(6) 2022.".
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; device remains implanted in patient.
Additional Manufacturer Narrative
Correction: please refer to h3 - reason code - other.The reported event was confirmed on the provided x-ray.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.The labelling clearly points out potential causes leading to implant breakage.Provided x-rays revealed the nail being bent at the level of the bone fracture.Surgeon¿s instruction regarding postoperative load application and the patient¿s behavior remained unknown.Provided patient information revealed a severe obesity resulting in the surgeon¿s opinion that obesity and atypical fracture were the factors for nail bending and should have been chipped.Without implant but with available information it could not be excluded that obesity and patient¿s behavior had contributed to the event.Above information leads to the conclusion that patient circumstances had contributed to the event.A product deficiency was not verified.In case further essential information becomes available we reserve the right to reopen the investigation and to reassess the root cause.H3 other text : the device has been explanted but the patient kept it "the patient wishes to take possession of the implant.".
Event or Problem Description
As reported: "after the surgery, the patient came to the hospital complaining of pain in the lower limbs, and an examination revealed a deformity of the nail.Revision surgery with plates is scheduled for (b)(6) 2022.".

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X300MM
• 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: 13418979
• Report Number: 0009610622-2022-00037
• Device Sequence Number: 20006167
• Product Code: HSB
• UDI-Device Identifier: 07613327286373
• UDI-Public: 07613327286373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 10/31/2025
• Device Model Number: 2333-0930S
• Device Catalogue Number: 23330930S
• Device Lot Number: K018C13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 76 KG