MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23330938S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2024
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
As reported: "380x9mm t2 alpha, operated 4 weeks ago, now nail is broken.Revision operation done with gamma3 implant.".
Additional Manufacturer Narrative
The reported event could be confirmed since the nail was returned in broken condition.The device inspection revealed the following: visual inspection the nail was completely broken in the thinned webs of the proximal drill hole at distal.The appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by missing plastic deformation, areas rubbed shiny and rough topography with smooth sections as well as secondary cracks.The incipient crack had started at the smallest cross section at lateral in the anterior web and had progressed towards medial.In this area the edge was damaged by a drill mark at distal.This was caused intra-operatively by contact with the step drill while preparing the cannulation for the locking screw.Removed material had weakened the material significantly.In the same web of the proximal fragment secondary cracks confirmed the origination of a fatigue fracture.Functional inspection: due to breakage no function was given.Dimensional inspection: manufacturing and inspection records confirmed the item had been released in accordance with specs.Dimensional inspection on the returned item could not be performed in the relevant areas because they had been deformed during the breakage process.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.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 the case presented an 80-year-old female patient (85 kg 164 cm mbi 31,6) had been treated with above nail on (b)(6) 2024, due to a spiraled shaft fracture of the right femur.On (b)(6) 2024, the nail was revised due to breakage.We received 7 x-ray-copies, in a-p- and l-m-view, showing the course of event: pre-op with broken bone, post-op with inserted nail and pre-revision with broken nail.They were forwarded to a hcp for medical review.From technical point of view, the nail failed in a fatigue fracture after an implantation period of approx.4 weeks.Material damage in the nail¿s drill hole, caused by contact with a drill, had weakened the cross section.Additional load application had contributed to the origin of an incipient crack.Found secondary cracks in the lateral edge of the proximal drill hole at distal indicate the origin of a fatigue fracture.From medical point of view, a medical expert mentioned that ¿the nail selection is likely to have/has contributed to the failure.One additional ap screw could have provided a little more stability to the construct and reduced the ml-load which finally led to the failure here.Although additional cerclages were used, it was failed to achieve an anatomical reduction of the fracture, which contributed to a prolonged consolidation.¿ based on the investigation, the root cause was attributed to a user related issue contributed by the patient¿s load application.With available information a product deficiency was not verified.If further information becomes available, we reserve the rights to re-open the investigation and to re-assess the root cause assessment.
Event or Problem Description
As reported: "380x9mm t2 alpha, operated 4 weeks ago, now nail is broken.Revision operation done with gamma3 implant.".

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19129483
• Report Number: 0009610622-2024-00157
• Device Sequence Number: 4682998
• Product Code: HSB
• UDI-Device Identifier: 07613327286496
• UDI-Public: 07613327286496
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Catalogue Number: 23330938S
• Device Lot Number: K069820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: 80 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG