MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø13X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-3360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/26/2022
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 a patient got pain, x-ray showed broken nail, the nail was removed and a new gamma3 nail was inserted.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product 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 progressing from lateral entrance to the medial through the bore.The misdrilling created a notch on the lateral side of the posterior web, which most likely created an incipient crack.The breakage initiated in a fatigue manner from the posterior web but broke in a much quicker manner from the anterior web.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest.Another thing to note apart from the drill marks was the sign of excessive loading.On the medial side of the distal portion of the nail, the bearing point shows signs of permanent deformation indicating towards overloading of the nail.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.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)].A formal medical opinion was sought from an independent medical professional based on the x-rays provided asking if the initial reduction was done properly and the probable reason for the fracture in which he stated that- ¿the preoperative x-rays are not provided.The attached post-operative x-ray and the x-ray after the failure of the nail only show an ap-view of the affected left hip.Therefore the assessment can only be given with a limitation.It seems as if there was a reversed oblique subtrochanteric fracture with (small) dislocation of the lesser trochanter present initially.The postoperative reduction with a gamma nail shows a fair reconstruction of the shaft and a center positioning of the lag screw with a reasonable distance to the apex of the femoral head.However, this is limited due to the missing lateral plane which would be necessary for a more substantiated judgement.The lesser trochanter was not addressed, which is acceptable in my opinion as the dislocation is only about 5mm.In summary i would assess the reduction as being okay.However, the fracture pattern is known to be associated with a higher proportion of failures.The failure is likely to be associated with the fracture pattern and thus patient related factors.The surgery seems as if it was performed technically fine with a good result.There is no obvious sign, that the there are factors related to the device, however, the breakage after 3 months is pretty early even with the given fracture pattern.It should be assessed, whether there is obvious damage to the lag screw hole of the nail, because that could be interpreted as a surgery related factor¿.Based on the above investigation and the opinion received from the health care professional, the root cause of the issue is most likely from both user and patient-related issue.The first reason being the complex fracture pattern and the second is the drill marks on the lag screw hole which had initiated the fracture and after some time it causes breakage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that a patient got pain, x-ray showed broken nail, the nail was removed and a new gamma3 nail was inserted.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø13X360MM 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: 14458913
• Report Number: 0009610622-2022-00192
• Device Sequence Number: 11936939
• Product Code: HSB
• UDI-Device Identifier: 04546540409911
• UDI-Public: 04546540409911
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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 Model Number: 3525-3360S
• Device Catalogue Number: 35253360S
• Device Lot Number: K05EBFE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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: 77 YR
• Patient Sex: Female