MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that 3 months after implantation of a proximal femur nail, the material broke.Additional information received: "the patient presented to our orthopedic trauma surgery department on (b)(6) 2021 with increasing symptoms and status after implantation of the above product.By means of ct ((b)(6) 2021) a fracture of the nail at the level of the thigh screw penetration could be detected.According to the patient, she already noticed a cracking during the rehabilitation stay with an increase in pain.In the course of the subsequent x-ray control, no complications could be detected.Consequences: failure of the bone fracture to heal subtrochanterically, revision with complete removal of the marrow and re-implantation of a long intramedullary nail osteosynthesis on (b)(6) 2021.Another rehabilitation measures.".
Event or Problem Description
It was reported that 3 months after implantation of a proximal femur nail, the material broke.Additional information received: "the patient presented to our orthopedic trauma surgery department on (b)(6) 2021 with increasing symptoms and status after implantation of the above product.By means of ct ((b)(6) 2021) a fracture of the nail at the level of the thigh screw penetration could be detected.According to the patient, she already noticed a cracking during the rehabilitation stay with an increase in pain.In the course of the subsequent x-ray control, no complications could be detected.Consequences: failure of the bone fracture to heal subtrochanterically, revision with complete removal of the marrow and re-implantation of a long intramedullary nail osteosynthesis on (b)(6) 2021.Another rehabilitation measures.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Significant drill marks were observed on the lateral side of the proximal end and progressing towards the medial side.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) somewhere at the lateral edge.Another thing to note apart from the drill marks was the sign of excessive loading which is also evident from material deformation at the medial end of the distal end of the nail as the material is bent in an outwards direction and the lateral edge of the proximal part showed slight deformation.The fracture pattern resembles a fatigue fracture, evident by the appearance of lines of rest.The breakage initiated in a fatigued manner from the anterior side but broke in a much quicker manner from the other side due to high tension.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.Based on the investigation, the failure of the nail can be attributed to a combination of user error which is evident from the misdrilling, and patient factors as excessive loading marks and material deformation are visible on the nail medial side and on the load-bearing side of the lag screw.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X320MM X 125°
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12421434
• Report Number: 0009610622-2021-00677
• Device Sequence Number: 11807506
• Product Code: HSB
• UDI-Device Identifier: 07613252274261
• UDI-Public: 07613252274261
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 09/30/2025
• Device Model Number: 3525-1320S
• Device Catalogue Number: 35251320S
• Device Lot Number: K0C8874
• 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: 08/10/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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: 66 YR
• Patient Sex: Female