MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported a broken gamma nail which required a revision surgery on (b)(6) 2021.11/25/2021 - additional information received: the patient presented on (b)(6) 2021 with pain.
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 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 medial part.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, indicating towards 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.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 instructions for use instructs user that: ¿avoid surface damage of implants.Discard all damaged or mishandled implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bending, reverse bending or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures (see operative technique manual).¿ based on investigation, the root cause was attributed to a user related issue.Appearance of mis-drilling marks indicates that the nail was damaged intra-operatively which may have led to weakening of the nail initially which over the period of time under fatigue stress led to nail breakage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported a broken gamma nail which required a revision surgery on (b)(6) 2021.11/25/2021 - additional information received: the patient presented on (b)(6) 2021 with pain.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12984954
• Report Number: 0009610622-2021-00818
• Device Sequence Number: 5302308
• Product Code: HSB
• UDI-Device Identifier: 07613153312734
• UDI-Public: 07613153312734
• 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): 04/21/2022

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: 03/31/2024
• Device Model Number: 3325-0320S
• Device Catalogue Number: 32250320S
• Device Lot Number: K0A2C1E
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2019
• 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; Hospitalization
• Patient Sex: Female