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

Model Number	2331-1034S
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	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the nail broke off postoperatively.The patient has a malignant tumor and the fracture was not healed.The revision took place on (b)(6) 2022.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail is broken apart as complained.The device inspection revealed the following: the nail is broken apart at the distal lag screw hole above the oblong hole.The proximal fragment was not returned for evaluation.Therefore the reported catalog- and lot number could not be confirmed as the laser markings are on this part of the nail.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, and missing plastic deformation and a residual fracture, in ductile manner, at medial.There are different deformations around the fracture face visible, afterwards it cannot be defined if these damages were caused with the drill during the insertion, during extraction or in-situ when the fragments rubbed against each other.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.The complaint was forwarded to medical affairs for review with following conclusion: "received information revealed a 60 year-old male patient, 161cm / 72kg, had been treated with above nail on (b)(6) 2022.Allegedly on (b)(6) 2023, the nail was revised due to breakage.The patient have a malignant tumor and the fracture was not healed.2 undated x-rays, both in ap-p-view, showed the nail post-operatively and a broken nail prior to revision.A medical review confirmed patient's disease and non-union." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by the reported non-union, which did finally lead to a fatigue failure of the nail.In this relation following statement of the t2 alpha¿ femur antegrade gt/pf nailing system instructions for use can be mentioned: "these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device." if more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the nail broke off postoperatively.The patient has a malignant tumor and the fracture was not healed.The revision took place on (b)(6) 2022.

• Brand Name: FEMORAL NAIL GT, LEFT 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: 16010518
• Report Number: 0009610622-2022-00591
• Device Sequence Number: 14901470
• Product Code: HSB
• UDI-Device Identifier: 07613327289435
• UDI-Public: 07613327289435
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 2331-1034S
• Device Catalogue Number: 23311034S
• Device Lot Number: K08E63F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 72 KG