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

Model Number	3525-1360S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2021 the hospital implant a nail 11x360, 125° 33250360ti, it has to be changed today because it was broken.The patient was revised on (b)(6) 2021.".
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2021 the hospital implant a nail 11x360, 125° 33250360ti, it has to be changed today because it was broken.The patient was revised on (b)(6) 2021." additional information received from surgeon - (b)(6) 2021: mr.S.A 67 year old patient of normal weight (95kg 180cm) broke his right femur on (b)(6) 2021 in the sense of a multifragmentary subtrochanteric fracture (ao 31 a3.3).The fracture was openly reduced on the same day and treated with a cerclage and a long g3 nail.Postoperatively, the patient was mobilized up to full weight bearing.The patient could be discharged quickly.9 weeks after treatment on 5.11.21, the patient, who had previously been symptom-free, suddenly had sc during normal walking, and the subsequent imaging showed a nail fracture.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Significant drill marks were found at the lateral entrance of the hole along the anterior side; they progress through the bore towards medial.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.Bearing points of lag screw at the lateral edge of the proximal part showed slight deformation, indicating towards high compressive load.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest.The breakage initiated in a fatigue 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A clinical opinion regarding the event was sought from an independent medical professional based on the available patient information and the provided x-rays.He opined that through initial fracture images, it is a clear that there was an extension of the fracture line in the femur, below the obvious dislocated fracture.These fractures are known for their instability even after fixation, so the construct needs to be very stable, especially if the patient is required to go full weight bearing.It is a matter of interest to know if the patient could have done without full weightbearing considering his high bmi or were there other reasons why this after care was chosen.The reduction of the fracture is technically not bad for these hard to reduce fractures.The lags crew is unfortunately not in the ideal position of the femoral head.Central or more dorsally where there is stronger bone would have been more ideal, especially if the patient was osteopenic or osteoporotic.With the extension of the fracture in mind and the relatively low wire, which is situated at the lower end of the dislocated fracture part, this was not a stable enough fixation, 1 or 2 additional wires proximal and distally to the first 1st wire might have added to a stable fracture fixation.The placed wire clearly did not hold the current fragment in place as shown in later images.Another aspect which is shown in the other images is the abundant callus formation, the body clearly tried to heal the fracture, however, due to much fracture movement it failed to heal, and the nail failed due to a lack of stability between the fractured parts.Based on the above investigation and available information, the root cause of the failure is deemed to be both user and patient related.Appearance of mis-drilling marks indicates that the nail was damaged intra-operatively which may have led to weakening of the nail initially.Further to this, slightly unstable fracture fixation and the simultaneous overloading on the whole construct ultimately led to the breakage of the nail and subsequently a distal locking screw as well, in a fatigue manner.The instruction for use clearly instructs the user that: ¿these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.[¿] 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.¿ [original statement(s)] if any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM 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: 12972103
• Report Number: 0009610622-2021-00812
• Device Sequence Number: 4442992
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 02/28/2025
• Device Model Number: 3525-1360S
• Device Catalogue Number: 35251360S
• Device Lot Number: K04FE2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG