MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0340S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not accessible for testing.If additional information becomes available, it will be provided in a supplemental report.Device implanted in the patient.
Event or Problem Description
It was reported that after inserting the lag screw, the set screw was installed and it was confirmed that the lag screw driver did not rotate.When the end cap was inserted, it became difficult to insert.After that it was checked by x-ray, it was in contact with the set screw that should have been inserted to the final position.After reinserting the set screw and confirming that the lag screw driver did not rotate, the surgery was completed.
Additional Manufacturer Narrative
The reported event could not be confirmed since no product and no medical records, i.E.X-rays had been provided.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.No nc/capa had been filed for the item in question.Potential cut-out had been considered in the risk management file.Following the event description it was concluded that the set screw initially has been placed / locked on the outer surface of the lag screw instead in the sliding flute.That position implied a non-rotating lag screw (driver) but with a set screw placed too high and avoiding suitable insertion of the end cap.The labelling clearly describes the correct placement of the set screw.Since the set screw is equipped with a safety ring a loosening of the set screw during operation is impossible.The set screw cannot unscrew by itself.Medical records were not provided.Unsuitable placements of set screw have been determined but intra-operative loosening has not been reported until date.With available information ¿ implant - assembling impaired ¿ an unsuitable placement of the set screw was concluded as root cause and being user related.In case substantive information or the item itself becomes available we reserve the right to re-open the investigation with root cause assessment.
Event or Problem Description
It was reported that after inserting the lag screw, the set screw was installed and it was confirmed that the lag screw driver did not rotate.When the end cap was inserted, it became difficult to insert.After that it was checked by x-ray, it was in contact with the set screw that should have been inserted to the final position.After reinserting the set screw and confirming that the lag screw driver did not rotate, the surgery was completed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM 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: 13059719
• Report Number: 0009610622-2021-00826
• Device Sequence Number: 1506056
• Product Code: HSB
• UDI-Device Identifier: 04546540375346
• UDI-Public: 04546540375346
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• 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): 02/24/2022

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: 01/31/2025
• Device Model Number: 3425-0340S
• Device Catalogue Number: 34250340S
• Device Lot Number: K0EABEA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2020
• 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: Unknown