MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X240MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1240S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The customer reports a surgical treatment of a subtrochanteric femur fracture on the left using a gamma 3 nail on (b)(6) 2021.After initially problem-free mobilization, increasing pain occurred.A ct of the left hip performed on (b)(6) 2021 shows a nail fracture at a typical location at the penetration point of the femoral neck screw with delayed consolidation with varus dislocation.Revision surgery was performed.
Event or Problem Description
The customer reports a surgical treatment of a subtrochanteric femur fracture on the left using a gamma 3 nail on (b)(6) 2021.After initially problem-free mobilization, increasing pain occurred.A ct of the left hip performed on (b)(6) 2021 shows a nail fracture at a typical location at the penetration point of the femoral neck screw with delayed consolidation with varus dislocation.Revision surgery was performed.
Additional Manufacturer Narrative
Please note correction to d4 lot number.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.Heavy metal chipping was also evident along the anterior wall.However, more significant thing to note apart from the drill marks was the sign of overloading.Bearing points of lag screw at the medial edge of the proximal hole showed significant deformation, indicating towards high compressive load.The fracture pattern resembles a fatigue fracture, evident by slight appearance of lines of rest.The breakage initiated in a fatigue manner but quickly broke instantaneously under high compressive loading.Mis-drilling was also evident in the distal oblong hole.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 x-rays.Question was asked regarding the potential contributing factors for breakage, to which he opined that a high non union rate at an unfavorable location is evident.Additionally, the patient is pretty old and shows severe arteriosclerosis as an indirect indicator for a poor metabolism including the tendency to show slow bone repair.Therefore, even after 4 months there was no union which contributed to failure of the device.Based on the above investigation and available information, the root cause of the failure is both user and patient related but predominantly patient related.Appearance of mis-drilling marks indicates that the nail was damaged intra-operatively which created a starting point for fracture but due to non-union and consequent overloading the nail broke.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X240MM 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: 12590066
• Report Number: 0009610622-2021-00739
• Device Sequence Number: 17163895
• Product Code: HSB
• UDI-Device Identifier: 07613252274223
• UDI-Public: 07613252274223
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 01/31/2025
• Device Model Number: 3525-1240S
• Device Catalogue Number: 35251240S
• Device Lot Number: K0E4BC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male