MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported: "patient who had left long gamma operation on (b)(6) 2019.The patient felt uncomfortable at the site of the surgery, and on (b)(6) 2020, the nail break was confirmed at the lag screw insertion site.It is possible that a load was applied when using the step drill.As a result, the non-union occurred.The side reduction may have been somewhat poor, or the patient have been drinking so much that this may have had an effect.A revision was made on (b)(6).".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient who had left long gamma operation on (b)(6) 2019.The patient felt uncomfortable at the site of the surgery, and on (b)(6) 2020, the nail break was confirmed at the lag screw insertion site.It is possible that a load was applied when using the step drill.As a result, the non-union occurred.The side reduction may have been somewhat poor, or the patient have been drinking so much that this may have had an effect.A revision was made on (b)(6).".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM 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; DE D-24232
• MDR Report Key: 9766334
• Report Number: 0009610622-2020-00078
• Device Sequence Number: 2512193
• Product Code: HSB
• UDI-Device Identifier: 04546540375735
• UDI-Public: 04546540375735
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 12/31/2022
• Device Model Number: 3525-0340S
• Device Catalogue Number: 35250340S
• Device Lot Number: K01C261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 51