MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "fracture of gamma nail at the femoral neck screw (left thigh) pain since end of (b)(6) 2021.The patient required a revision surgery.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Please note correction to: d4 lot #, the lot number provided is not valid.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.The proximal portion was not returned for evaluation.Signs of any intra-op mis-drilling was not found.However, a significant thing to note 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 and presence of shiny surface.The breakage initiated in a fatigue manner but quickly broke instantaneously under high compressive loading.The batch record could not be reviewed because the portion containing the device information was not returned and lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the above investigation and the available information, the root cause of the failure is deemed to be patient related.Factors like nail breaking in a fatigue manner, evidence of overloading and the fact that the breakage occurred after more than one year of implantation (including patient falling from cycle) are clear enough to indicate that the breakage happened due to patient related factors than any deficiency in the device itself.The instruction for use clearly indicates that: ¿the implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "fracture of gamma nail at the femoral neck screw (left thigh) pain since end of (b)(6) 2021.The patient required a revision surgery.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM 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: 12867650
• Report Number: 0009610622-2021-00805
• Device Sequence Number: 12247655
• Product Code: HSB
• UDI-Device Identifier: 04546540375759
• UDI-Public: 04546540375759
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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 Model Number: 3525-0380S
• Device Catalogue Number: 35250380S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 110 KG