MAUDE Adverse Event Report: STRYKER GMBH SET SCREW, TI GAMMA3® Ø8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30030822S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed based on the information provided.It has been confirmed by the user that the reported event is not related to the product itself.Therefore, no device inspection would have been necessary.Based on investigation, the root cause was attributed to an user related issue.The hcp failed to properly follow the instructions and forgot to use the set screw, which is clearly stated as mandatory.As a reminder, the instructions for use clearly state that: ¿the set screw must be used.The use of the set screw is not an option.¿ the lot number was not communicated, but the event is not related to the implant itself, therefore, no product history review would have been necessary.The labelling review confirmed the off-label use.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not returned.
Event or Problem Description
As reported: "after completion of an orif implanting gamma3 in right femur for proximal femoral fracture on (b)(6) 2023, the doctor realized he forgot to use the set screw in the surgery.".
Event or Problem Description
As reported: "after completion of an orif implanting gamma3 in right femur for proximal femoral fracture on (b)(6) 2023, the doctor realized he forgot to use the set screw in the surgery.".

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• 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: 18563723
• Report Number: 0009610622-2024-00042
• Device Sequence Number: 12444064
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/21/2024

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: 30030822S
• Device Lot Number: UNKNOWN
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/21/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Prefer Not To Disclose