MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1400S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	08/08/2019
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 remains implanted.
Event or Problem Description
As reported: "long gamma nail with 2 dall miles cables.Proximal portion of the nail broke.Revision surgery required.".
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation, an x-ray was provided by the customer which supported the event.A device inspection was not possible since the affected device was still implanted in the patient.A clinical statement was requested to hcp, based on the one x-ray in a/p view provided by customer.¿the fracture is unfavorable in terms of stability and for this reason the surgeon has probably decided to use the cables for additional stability.There seems to be a very long medial fragment, that has to be stabilized.However, despite the cables the medial support is reduced.Therefore, a higher load was on the nail and the lag screw.The initial reduction of the fracture seems to be pretty well.It cannot be said with one x-ray whether the bone is osteoporotic or osteopenic.Likely, but there are no clean signs, and this would have contributed only little to the failure.The race between the healing of the fracture and the expected failure of the nail has unfortunately ended unfavorably with a fracture of the nail.¿ based on the clinical opinion fracture was highly unstable and the load got transmitted on the nail and it broke subsequently.A review of the labeling did not indicate any abnormalities.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.Due to insufficient information and product not returned the exact root cause could not be provided.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "long gamma nail with 2 dall miles cables.Proximal portion of the nail broke.Revision surgery required.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM 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: 9434352
• Report Number: 0009610622-2019-00953
• Device Sequence Number: 19482199
• Product Code: HSB
• UDI-Device Identifier: 07613252273851
• UDI-Public: 07613252273851
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 08/31/2022
• Device Model Number: 3425-1400S
• Device Catalogue Number: 34251400S
• Device Lot Number: K01F1B6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/20/2020
• 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: 69 YR