MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D12XL360; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1236S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
It was reported; "the doctor used a t2 alpha retrograde nail on a periprosthetic fracture.When implanting the nail, the fracture was well reduced.When the nail was fully inserted it kicked the fracture into extension.He was frustrated that he didn't use a competitor's nail with the 10 deg bend.There's no immediate consequences.The fracture just has a smaller chance of healing appropriately since it is now in about 8 deg of extension.".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
It was reported; "the doctor used a t2 alpha retrograde nail on a periprosthetic fracture.When implanting the nail, the fracture was well reduced.When the nail was fully inserted it kicked the fracture into extension.He was frustrated that he didn't use a competitor's nail with the 10 deg bend.There's no immediate consequences.The fracture just has a smaller chance of healing appropriately since it is now in about 8 deg of extension.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on details available an exact root cause could not be confirmed but it could not be excluded that the reported event is rather related to the user [inappropriate nail chosen], which is confirmed by event description ¿¿when the nail was fully inserted it kicked the fracture into extension.He was frustrated that he didn't use a competitor's nail with the 10 deg bend.¿.The labelling clearly points out the importance of correct implant selection and sizing and that any failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.With details provided no deviation for the nail in question was verified.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported; "the doctor used a t2 alpha retrograde nail on a periprosthetic fracture.When implanting the nail, the fracture was well reduced.When the nail was fully inserted it kicked the fracture into extension.He was frustrated that he didn't use a competitor's nail with the 10 deg bend.There's no immediate consequences.The fracture just has a smaller chance of healing appropriately since it is now in about 8 deg of extension.".

• Brand Name: T2 FE RETRO NAIL LNG D12XL360
• 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: 13509386
• Report Number: 0009610622-2022-00046
• Device Sequence Number: 4228143
• Product Code: HSB
• UDI-Device Identifier: 07613327292923
• UDI-Public: 07613327292923
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2339-1236S
• Device Catalogue Number: 23391236S
• Device Lot Number: K0A48FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Female