MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1400S
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	07/18/2022
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
It was reported that gamma nail and screw broke.Implantation took place in (b)(6) 2022.Patient stated to the physician that he had followed the physician's instructions, but had noticed pain whilst walking.Explantation and simultaneous implantation of a new gamma3 nail.
Event or Problem Description
It was reported that gamma nail and screw broke.Implantation took place in may 2022.Patient stated to the physician that he had followed the physician's instructions, but had noticed pain whilst walking.Explantation and simultaneous implantation of a new gamma3 nail.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.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 found at the lateral entrance of the hole along the posterior 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.The mis-drilling had also extended to the upper side of the proximal lateral edge, leading to severe deformation.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.The medial edge of the distal part also showed signs of deformation, heavier than the proximal one.This indicates towards application of 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 and loading.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 given x-ray.Question regarding breakage was asked to which he responded: "there are patient related factors (the fracture pattern with a subtrochanteric fracture just below the lesser trochanter) -other information is difficult to assess from only one plane (there is the axial plane missing and pre-or at least directly postoperative x-ray would be helpful, here!).Surgical factors also could have influenced the failure (miss-drilling can reduce the resistance to load significantly).We see a hypertrophic non-union (this may indicate too much micromotion at the fracture site).Therefore the scenario would be: misdrilling led too reduced resistance to load, micromotion led to hypertrophic non-union, finally the fracture did not consolidate and failure with breakage occurred." 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, non-union 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 a position 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 additional information is received, the record will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15260081
• Report Number: 0009610622-2022-00382
• Device Sequence Number: 15131126
• Product Code: HSB
• UDI-Device Identifier: 07613252274315
• UDI-Public: 07613252274315
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 08/31/2026
• Device Model Number: 3525-1400S
• Device Catalogue Number: 35251400S
• Device Lot Number: K006983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 59 YR
• Patient Sex: Male