MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84251380S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to medial migration of the lag screw.The lag screw was not engaged.It was not fully set or centered in the groove.The surgeon revised with a shorter rc.There was minimal purchase in the head.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to medial migration of the lag screw.The lag screw was not engaged.It was not fully set or centered in the groove.The surgeon revised with a shorter rc.There was minimal purchase in the head.
Additional Manufacturer Narrative
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.In the case presented a (b)(6) year-old male patient had been treated with above implant on (b)(6) 2024.On (b)(6) 2024, the patient was revised due to medialization of the set screw.The revision surgeon stated the following: >> i did see this case last week from one of my partners.It was very difficult to revise.¿local rep¿] tells me that the surgeon always cranks down the set screw.It certainly wasn¿t engaged or that would not happen.I¿d say it wasn¿t fully set or centered in the groove.I revised it with a shorter rc.We will see how that works.He¿s 90 and there was minimal purchase in the head.<< further information was not available.The labeling instructs not to unscrew the set screw for more than ¼ of a turn.Referring to the revision surgeon the set screw had not been placed adequately.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.With available information a real root cause could not be determined.With available information a product deficiency was not verified.

• Brand Name: LONG NAIL, RIGHT GAMMA4 Ø11X380MM 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: 19844913
• Report Number: 0009610622-2024-00717
• Device Sequence Number: 12418941
• Product Code: HSB
• UDI-Device Identifier: 07613327479553
• UDI-Public: 07613327479553
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 84251380S
• Device Lot Number: K18C314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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: 89 YR
• Patient Sex: Male