MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3125-1200S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a nail broke in the area of the femoral neck screw when attempting to drive the nail out after removing the locking screw and femoral neck screw.There was prolonged surgery time because the access in the trochanter had to be enlarged and also a conical extractor had to be used to remove the rest of the rest of the broken nail.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.Please also note the corrections to h6 clinical signs and h6 health impact codes.The reported event could be confirmed based on the picture received.The evidence inspection revealed the following: it was possible the confirm the identification of the nail based on the catalog # and the lot # marked.The nail is broken in two parts, at the level of the proximal hole, thus the complaint could be confirmed.However, no picture of the breakage was received and no information about the patient's health and post-operative activity was communicated.Therefore, it was not possible to make any statement on the root cause of the implant failure.Based on investigation, the root cause could not be determined.The device needs to be returned for investigation or clear pictures of the breakage have to be sent in order to be able do define the cause of the implant 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that a nail broke in the area of the femoral neck screw when attempting to drive the nail out after removing the locking screw and femoral neck screw.There was prolonged surgery time because the access in the trochanter had to be enlarged and also a conical extractor had to be used to remove the rest of the the rest of the broken nail.Additional information received from the sales rep: when trying to remove the nail, it was found that it was broken.This statement means that it was a planned surgery.A hip implantation was planned, and the nail had to be removed.
Event or Problem Description
It was reported that a nail broke in the area of the femoral neck screw when attempting to drive the nail out after removing the locking screw and femoral neck screw.There was prolonged surgery time because the access in the trochanter had to be enlarged and also a conical extractor had to be used to remove the rest of the rest of the broken nail.Additional information received from the sales rep: when trying to remove the nail, it was found that it was broken.This statement means that it was a planned surgery.A hip implantation was planned, and the nail had to be removed.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed.The evidence inspection revealed the following: the identification of the returned nail was confirmed based on the catalog # and the lot # marked.The nail is broken in two parts, at the level of the proximal hole, both parts were returned.The reported failure could be confirmed and the functionality of the implant cannot be given anymore.The evaluation revealed that the nail broke in a fatigue fracture, as confirmed by the presence of striations on one side of the broken surface.The period of implantation was not communicated.According to the damage observed, the fatigue fracture had its origination in the lateral side of the proximal hole.In this area, significant material damage had weakened the device, which was caused by misaligned drilling.This statement is confirmed by the fact that only one side of the proximal hole shows significant signs of misdrilling and wear.Material wear and deformation on the medial edge of the proximal hole was most likely caused by increased axial loading during the implantation period; which is considered as patient behavior related.Severe damage can be observed on the edge of the proximal hole, below the lag screw.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw and the breakage of the nail.This statement is confirmed by the wear marks observed on the returned lag screw.No wear or deformation was observed on the distal locking holes.Since no x-ray was received and the patient behavior or period of implantation were not communicated, it was not possible to make any statement regarding the health and bone condition of the patient or to make a possible correlation between bone mal-union/non-union and the implant failure.Based on investigation, the root cause was attributed to an user related issue.The misaligned drilling, creating a weak spot on the implant's proximal hole most certainly contributed to the nail breakage.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: 15996807
• Report Number: 0009610622-2022-00585
• Device Sequence Number: 14978273
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: 04546540375087
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2023

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: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 3125-1200S
• Device Catalogue Number: 31251200S
• Device Lot Number: K0EBA90
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 03/22/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/06/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female