MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3430-1380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that a gamma nail was being implanted and broke."was a subtroch fracture nailed implant fracture at 2 months; revised to a proximal femoral replacement.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that a gamma nail was being implanted and broke."was a subtroch fracture nailed implant fracture at 2 months; revised to a proximal femoral replacement.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device was found to be broken around the proximal region at the point of the lag screw insertion hole.Significant drill marks were found at the lateral entrance of the hole along the posterior side and then progressing through the bore towards medial.The surface revealed that the breakage originated from the posterior web.Bearing points of lag screw at the distal part showed slight deformation, indicating towards high compressive load.The initial smooth surface as well as the appearance of lines of rest/waves confirmed the breakage to be a fatigue fracture.Also, the fracture pattern suggests that after a while the breakage was abrupt.The breakage initiated in a fatigue manner from the posterior web but broke in a much quicker manner from the anterior web due to high tension.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.The optec states that: ¿in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ based on the above investigation and the available information, the root cause of the issue is a combination of both user and patient related, but predominantly user related due to the nature of intra-op damage to nail which may have led to weakening of the nail initially.There was deformation observed as well on the medial side of the nail at the lag screw bearing point, indicating towards high compressive load (most likely patient related).If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that a gamma nail was being implanted and broke."was a subtroch fracture nailed - implant fracture at 2 months - revised to a proximal femoral replacement.".
Additional Manufacturer Narrative
Correction: please refer to h1 summary report & h1 number of events summarized.Please note the h1 summary report tab and h1 number of events summarized tab were selected in error.
Event or Problem Description
It was reported that a gamma nail was being implanted and broke."was a subtroch fracture nailed - implant fracture at 2 months - revised to a proximal femoral replacement.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 130°
• 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: 13546463
• Report Number: 0009610622-2022-00051
• Device Sequence Number: 17424733
• Product Code: HSB
• UDI-Device Identifier: 07613252273998
• UDI-Public: 07613252273998
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2022

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: 11/30/2025
• Device Model Number: 3430-1380S
• Device Catalogue Number: 34301380S
• Device Lot Number: K087028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 06/07/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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; Hospitalization
• Patient Sex: Unknown