MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X280M; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251280S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2024
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
As reported : ''the customer reports a broken gamma nail, the revision surgery is planned for (b)(6) 2024.''.
Event or Problem Description
As reported: ''the customer reports a broken gamma nail, the revision surgery is planned for (b)(6) 2024.''.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail was returned broken, as reported.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.On the proximal side, instantaneous breakage can be seen at medial.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.Drill marks and deformation were found at the lateral entrance.The drill marks were most likely caused by miss-drilling during lag screw reaming which created the starting point of the fracture somewhere at the lateral edge.On the distal side, heavy material deformation can be seen which most likely had contributed to the starting point of the fracture at lateral.The lag screw bearing point shows strong impression marks and deformation which may come from the high compressive load, indicating the nail was exposed to continuous high load over a longer period of time.Therefore, the breakage pattern resembles a fatigue breakage of the nail.The breakage was most likely initiated due to initial miss-drilling and broke instantaneously from the other side due to high tension and loading over time.The broken nail was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, the implantation date is unknown and neither x-rays, nor operation report, nor information about patient activity was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue caused by high loads did lead to the breakage of the device.The visible drill marks also played a certain role as such marks have an influence on the lifetime of the nail.As a reminder, the operative technique states the following: 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.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 more information is provided, the case will be reassessed.
Additional Manufacturer Narrative
Please note update to device codes.
Event or Problem Description
As reported: ''the customer reports a broken gamma nail, the revision surgery is planned for (b)(6) 2024.''.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X280M
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19860063
• Report Number: 0009610622-2024-00722
• Device Sequence Number: 15479361
• Product Code: HSB
• UDI-Device Identifier: 07613252273790
• UDI-Public: (01)07613252273790(17)271130(10)K05DEA7
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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 Catalogue Number: 34251280S
• Device Lot Number: K05DEA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 11/14/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/17/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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 Sex: Unknown