MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL SHT D13XL200; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1320S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "while inserting a 32.5mm advanced screw into the distal hole on the proximal side of the 200mm nail of the t2 alpha retronail, it got stuck and the head floated 8mm and was not fixed bicortically." the implant was placed and the surgery was completed.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.A formal medical opinion was sorted for available radiograph and surgeon query.¿how i should remove this screw because the female hole in the screw head and the threads on the periphery are licking.¿ the screw should have been removed in the very operation it was introduced.With time and further load application on it, it will probably not be easier to remove it if there are no relevant problems now in opinion, the screw can be left in the femur.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.
Event or Problem Description
As reported: "while inserting a 32.5mm advanced screw into the distal hole on the proximal side of the 200mm nail of the t2 alpha retronail, it got stuck and the head floated 8mm and was not fixed bicortically.".The implant was placed and the surgery was completed.

• Brand Name: T2 FE RETRO NAIL SHT D13XL200
• 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: 16282411
• Report Number: 0009610622-2023-00023
• Device Sequence Number: 15145172
• Product Code: HSB
• UDI-Device Identifier: 07613327293197
• UDI-Public: 07613327293197
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: 2339-1320S
• Device Catalogue Number: 23391320S
• Device Lot Number: K0F1AC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: 57 YR
• Patient Sex: Female