MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1280S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported: "the surgery was almost complete when the aiming device was to be removed, it was not detachable.The aiming device cannot be removed from the long gamma nail.There was a quasi cold connection between the implant and the insertion aid.Consequence: removal of the already fully implanted nail incl.Femoral neck screw and distal locking and re-implantation of a new nail.The procedure was delayed by 1h which lead to higher blood loss.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned devices were received in a disassembled state.No visual damage to nail was observed post decontamination, pre-surgical test was conducted for the returned devices.Upon inspection, the devices were functionally ok.While inserting the nail holding screw in the target device slight resistance could be felt but parts could be assembled and disassembled 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.Based on the above investigation, the root cause of the issue is most likely user related.The percolated blood in targeting arm most likely caused cold welding resulting in jamming of the devices making it difficult to disassemble if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: "the surgery was almost complete when the aiming device was to be removed, it was not detachable.The aiming device cannot be removed from the long gamma nail.There was a quasi cold connection between the implant and the insertion aid.Consequence: removal of the already fully implanted nail incl.Femoral neck screw and distal locking and re-implantation of a new nail.The procedure was delayed by 1h which lead to higher blood loss.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM 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; 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: 14487171
• Report Number: 0009610622-2022-00207
• Device Sequence Number: 11964476
• Product Code: HSB
• UDI-Device Identifier: 07613252273790
• UDI-Public: 07613252273790
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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 Expiration Date: 08/31/2025
• Device Model Number: 3425-1280S
• Device Catalogue Number: 34251280S
• Device Lot Number: K08616E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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 Sex: Male