MAUDE Adverse Event Report: STRYKER GMBH G4 LONG NAIL LEFT D10XL320MM X 120DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 85200320S

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device is retained by the hospital.

Event Description

As reported: "gamma 4 long nail was implanted, but the lag screw migrated postoperatively and the fracture reduction collapsed.Revision surgery is scheduled on (b)(6) 2023.".

Event Description

As reported: "gamma 4 long nail was implanted, but the lag screw migrated postoperatively and the fracture reduction collapsed.Revision surgery is scheduled on (b)(6) 2023.".

Manufacturer Narrative

The reported event could not be confirmed; but a displaced proximal bone fragment was confirmed on a provided x-ray copy.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.No indications of material, manufacturing or design related problems were found during the investigation.The device was not returned for investigation.4 x-ray-copies were provided which were forwarded for medical review.The summarized findings of the medical expert¿s: the event description could not be confirmed due to poor image quality.Focusing on the initial bone fracture; ¿it is very understandable though that this event could have occurred in this fracture type with the limited stabilization of this highly unstable fracture.The biomechanics of this fracture type were fully not addressed when only inserting the gamma nail.¿ if the device is returned or if any additional information is provided, we reserve the rights to reassess the investigation including root cause.The root cause of this event was regarded as user related.With given information a deficiency of the device was not verified.

• Brand Name: G4 LONG NAIL LEFT D10XL320MM X 120DEG
• Type of Device: 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: 17939781
• MDR Text Key: 325737103
• Report Number: 0009610622-2023-00351
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327476583
• UDI-Public: 07613327476583
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 85200320S
• Device Lot Number: K162318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention