MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3066-0080S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
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
As reported: "cut out of lag screw occurred and a revision surgery with tha was performed.".
Additional Manufacturer Narrative
Please note the corrections to h6 clinical signs, h6 results and h6 conclusion codes.The reported event could be confirmed from the available radiographs.With the available radiographs, a formal medical opinion was sought:- it is a case about a long gamma nail that was implanted in (b)(6)2022 for a less/ instable pertrochanteric fracture (ao 31a1 or even 31a2), which cannot be sure from available radiographs.The post-operative pics are only in one direction, and the angle is not even ideal to judge the reposition completely.Looking critically one may think the tad is not within the safe range (<25mm), a tad larger than 25mm has a higher risk of the cutout.After 28 days it seems like a secondary dislocation occurred, probably related to the sliding of the lag screw.Also, it looks like there is quite a lot of bone resorption in the fracture line(s).In september you can also see resorption around the tip of the lag screw.Whether the continuous movement in the proximal part of the fracture leads to non-union, or whether non-union lead to the movement is unclear.In november hardly any callus is seen, which would suggest a non-union.The cutout is confirmed in september and very clear in november of 2022.The cutout is probably related to several issues, a too-large tad, a not-ideal reposition of the fracture, too much movement in the fracture parts, and as a consequence a non-union.A review of the device history was not possible because the lot number was not communicated.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 can be attributed to a combination of primary patient related and user related.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "cut out of lag screw occurred and a revision surgery with tha was performed.".

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X80MM
• 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: 16010431
• Report Number: 0009610622-2022-00589
• Device Sequence Number: 20279716
• Product Code: HSB
• UDI-Device Identifier: 04546540595966
• UDI-Public: 04546540595966
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 3066-0080S
• Device Catalogue Number: 30660080S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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