MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251280S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/22/2023
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.
Event or Problem Description
As reported: "breakage of the intramedullary nail used for femur fracture surgery.The patient required revision surgery.".
Additional Manufacturer Narrative
Please note corrections to section d9/h3, the device was returned for inspection; and h6 (method code).The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Severe drill marks were found at the lateral entrance of the hole along the posterior web on the proximal side of the nail; they progress inwards 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 on the posterior web.The fracture pattern resembles a fatigue fracture, evident by partially visible lines of rest, relatively smooth fracture surface on initiation side and abrupt feature on the other side.The breakage initiated in a fatigue manner and broke instantaneously 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 formal medical opinion was taken from our hcp regarding the case and the available x-rays.The hcp opined that it was a highly unstable proximal femur fracture/ reverse trochanteric fracture.The reduction was sub-optimal, and the lag screw was placed in the wrong area of the femoral head.The biomechanics of the fracture are not taken into account and the nail selected was relatively short.Six months after the surgery this fracture looks to end up as a non-union, there is hardly any callus formation.The inadequate reduction may have contributed to the lack of callus formation.Furthermore, the intrinsic fracture instability - which was not accounted for enough with the chosen implant - caused continuous movement in the lag-screw-nail interface.Another contributor here may have been the placement of the lag screw in the front part of the femoral head instead of dead center or slightly in the back, this is also considered to be a weaker part of the femoral head.From a biomechanical and medical perspective, multiple factors led to the nail breakage.Based on the above investigation, the root cause of the issue is deemed to be user related.The inadequate fracture reduction and procedure followed most likely led to a non-union causing excessive loading on the nail, thereby leading to its breakage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "breakage of the intramedullary nail used for femur fracture surgery.The patient required revision surgery." update: the patient complained pain on 27/07/23.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM 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: 18117949
• Report Number: 0009610622-2023-00411
• Device Sequence Number: 15200621
• Product Code: HSB
• UDI-Device Identifier: 07613252273790
• UDI-Public: 07613252273790
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 34251280S
• Device Lot Number: K030663
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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 Age: 86 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG