MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
"client reported broken gamma 3 nail at 6 weeks post operative.Revision surgery needed to remove broken nail and replace with other implant".
Additional Manufacturer Narrative
The reported event was confirmed.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 nail breakage had been considered in the risk management file.Potential reasons for nail breakage are listed in the labelling.Physical investigation of the nail revealed it broke in a fatigue manner, originated by material damage at lateral in the posterior web of the proximal drill hole.Additionally, the nail was heavily loaded during the implantation period.Material and manufacturing deficiencies were not detected.X-rays were provided and were presented to a healthcare professional for review.His opinion was (in extracts): ¿very young patient¿seems to be in a very bad overall health status.¿if she is still having alcohol consumption, she may have been very careless with the weight bearing¿.Lag screw placed exactly through the laterally opened fracture.All of this may have contributed to the poor outcome.¿ with available information a deficiency of the device was not verified.The cause of the event was determined being patient related contributed by intra-operative material damage.¿ an unsuitable placement of the lag screw was concluded as root cause and being user related.In case further substantive information becomes available we reserve the right to re-open the investigation with root cause assessment.
Event or Problem Description
"client reported broken gamma 3 nail at 6 weeks post operative.Revision surgery needed to remove broken nail and replace with other implant".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13114424
• Report Number: 0009610622-2021-00832
• Device Sequence Number: 17317545
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: 07613252273837
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 3425-1360S
• Device Catalogue Number: 34251360S
• Device Lot Number: K0BBD18
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 64 KG