MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D10XL340; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1034S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a t2 alpha retrograde nail was discovered to be broken at the most proximal screw hole in the distal cluster of the nail.The screw was found to be broken during explantation of the nail.Patient was given weight bearing as tolerated instructions postoperatively.Patient was revised to a t2 scn with endcap.Primary implant date was on (b)(6) 2022.Patient took notice on (b)(6), after falling down and feeling pain.Nail has been returned.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail was separated by a fatigue fracture.The appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by lines of rest and missing plastic deformation.The lateral entry of the broken drill hole did not show any drilling or contact marks; the hole was not occupied by a screw.The incipient crack was at lateral, supported by a small secondary crack.A bright area was visible on the outer surface proximal to the fracture site, probably created by contact with a screw.Drill marks from a drill were not visible; therefore, a deliberate placement of a screw can be pre-supposed.Dimensional inspection indicates that the device is within the specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.Two undated x-rays in a-p- and ml-view were provided.They were showing the distal area with condyle locking and nail breakage.The nail had broken at the level of the bone breakage 1 screw had been placed outside the nail, proximally to the nail breakage.It was concluded this screw had been placed deliberately.Since no other x-rays were available for comparison a medical review was not justified.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a t2 alpha retrograde nail was discovered to be broken at the most proximal screw hole in the distal cluster of the nail.The screw was found to be broken during explantation of the nail.Patient was given weight bearing as tolerated instructions postoperatively.Patient was revised to a t2 scn with endcap.Primary implant date was (b)(6) 2022.Patient took notice on 28-sep, after falling down and feeling pain.Nail has been returned.

• Brand Name: T2 FE RETRO NAIL LNG D10XL340
• 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: 15672328
• Report Number: 0009610622-2022-00475
• Device Sequence Number: 6348060
• Product Code: HSB
• UDI-Device Identifier: 07613327292442
• UDI-Public: 07613327292442
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 2339-1034S
• Device Catalogue Number: 23391034S
• Device Lot Number: K0B82E7
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: 61 YR
• Patient Sex: Female