MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X260MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250260S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "fracture of the implant in the area of the femoral neck screw hole.Revision surgery planned on (b)(6) 2023.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
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 nail is completely broken in the webs of the proximal lag screw hole.The lag screw bearing point on the medial side at the distal end shows deformation which is from the high compressive load.This deformation indicates that the nail was exposed to continuous high loads over a longer period of time.The breakage pattern resembles a fatigue breakage of the nail.The device history record could not be reviewed because the part which contain the lot and catalog number of affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the exact root cause could not be established.More detailed information about the complaint event as well as the proximal part of the affected device must be available in order to determine the root cause of the complaint event.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "fracture of the implant in the area of the femoral neck screw hole.Revision surgery planned on (b)(6) 2023.".

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X260MM 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: 17584951
• Report Number: 0009610622-2023-00284
• Device Sequence Number: 14348631
• Product Code: HSB
• UDI-Device Identifier: 07613153313410
• UDI-Public: 07613153313410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: Lay User/Patient
• Device Catalogue Number: 33250260S
• Device Lot Number: UNKNOWN
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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