MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/07/2023
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.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "z.N.Treatment of a subtrochanteric femur fracture with a long gamma nail (11mm x 360mm x 125°; femoral neck screw 115mm).Postoperative follow-up with partial weight bearing for 8 weeks.Presentation via central emergency department after fall with pain in the hip.Radiologically showed fracture of both distal screws as well as the gamma nail in the area of the femoral neck screw.Revision surgery was performed with removal of the fractured gamma nail and re-osteosynthesis with a femoral nail.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned and no additional information was available.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "(b)(6) treatment of a subtrochanteric femur fracture with a long gamma nail (11mm x 360mm x 125°; femoral neck screw 115mm).Postoperative follow-up with partial weight bearing for 8 weeks.Presentation via central emergency department after fall with pain in the hip.Radiologically showed fracture of both distal screws as well as the gamma nail in the area of the femoral neck screw.Revision surgery was performed with removal of the fractured gamma nail and re-osteosynthesis with a femoral nail.".
Event or Problem Description
As reported: "z.N.Treatment of a subtrochanteric femur fracture with a long gamma nail (11mm x 360mm x 125°; femoral neck screw 115mm).Postoperative follow-up with partial weight bearing for 8 weeks.Presentation via central emergency department after fall with pain in the hip.Radiologically showed fracture of both distal screws as well as the gamma nail in the area of the femoral neck screw.Revision surgery was performed with removal of the fractured gamma nail and re-osteosynthesis with a femoral nail.".
Additional Manufacturer Narrative
Please note correction to d9/h3 and h6 (results and conclusion codes).The reported event could be confirmed, since the device was returned and matches the alleged failure.The received nail is completely broken in the webs of the proximal lag screw hole.We can see the misdrilling marks at the proximal end of the nail and the load-bearing points at the medial edge.We can see lines of rest which indicate that the initiation of breakage happened in a fatigued manner, but we also have the deformation posterior end which indicates that the complete breakage happened instantaneously in a brittle manner which is most likely caused by the fall of the patient.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 root cause was attributed to patient related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°
• 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: 17738015
• Report Number: 0009610622-2023-00311
• Device Sequence Number: 20552042
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: 07613252273837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2024

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: 34251360S
• Device Lot Number: K0CE30B
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 02/09/2024
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/19/2023; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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 Sex: Unknown