MAUDE Adverse Event Report: STRYKER GMBH INTERMEDIATE NAIL, LEFT GAMMA4 Ø10X240MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	83250240S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported after the first use of gamma 4 without the presence of the sales rep, the doctor noticed that he forgot to tighten the set screw.
Event or Problem Description
It was reported after the first use of gamma 4 without the presence of the sales rep, the doctor noticed that he forgot to tighten the set screw.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Nonetheless, based on the information provided, it could be confirmed that the root cause of the reported event is user related.Hcp failed to properly follow the instructions of the operative technique and to perform the operation with care.As a reminder the use of the set screw is mandatory as its absence could lead to major postoperative complications.A proper fixation and placement of the lag screw cannot be ensure without the set screw.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.If the device is returned of if more information is provided, the case will be reassessed.

• Brand Name: INTERMEDIATE NAIL, LEFT GAMMA4 Ø10X240MM 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: 20483716
• Report Number: 0009610622-2024-00873
• Device Sequence Number: 4208829
• Product Code: HSB
• UDI-Device Identifier: 07613327593877
• UDI-Public: (01)07613327593877(17)340331(10)K1AE18C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• 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): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 83250240S
• Device Lot Number: K1AE18C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female
• Patient Weight: 45 KG