MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31250170S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a broken gamma3 nail and required revision surgery.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
The customer reported a broken gamma3 nail and required revision surgery.
Additional Manufacturer Narrative
Correction: please refer to sections d9/h3 the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received nail was visually inspected in which we can see that it is broken in the webs of the proximal lag screw hole.Misdrilling marks were found at the lateral entrance of the hole along one of the sides in both the proximal and distal halves; they progress inwards through the bore towards the medial.We can also see that the material is chipped off at the lateral end of the proximal part of the nail.These marks were generated by the lag screw step drill which most likely had created the starting point of the fracture (notching effect).With the drill marks, we can also see signs of excessive loading.At the medial edge of the distal part, we can see signs of heavy deformation from the load bearing.This indicates towards application of high compressive load.The microscopic picture of the breakage indicates breakage in a fatigued manner, evident from lines of rest, and smooth fracture surface on the initiation side.The breakage was initiated in a fatigued manner from the side where the drill marks could be seen and broke instantaneously from the other side due to high tension and loading.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.Based on the investigation, the root cause was attributed to user-related as we can see the misdrilling marks on the distal and proximal end which led to the initiation of fatigue breakage with heavy load bearing deformations.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125°
• 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: 19671172
• Report Number: 0009610622-2024-00337
• Device Sequence Number: 6851794
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 31250170S
• Device Lot Number: K18445E
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: 85 YR
• Patient Sex: Female