MAUDE Adverse Event Report: INOMED MEDIZINTECHNIK GMBH OPTIPIN FIXIATION PIN 60MM

Model Number	803364
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure preparation for a seeg surgery, the surgeon had secured the headring with optipins to the patient's head.The representative noticed that the front left pin appeared to be flexed and informed this issue to the surgeon, and recommended that they adjust the pin and ring in order for the optipin to be more orthogonal to the bone for optimal fixation of the frame.When the surgeon was removing the optipin using the torque wrench, the pin snapped.And this abrupt snapping also contributed to the front pin on the right snapping almost in the same moment.This also leading to slipping of the patient head and caused the the skin at the back of the patiens head to be lacerated.A 15-minute delay was noted.

• Brand Name: OPTIPIN FIXIATION PIN 60MM
• Common Device Name: FIXIATION PIN
• Manufacturer (Section D): INOMED MEDIZINTECHNIK GMBH; im hausgruen 29; 79312; emmendingen, baden-württemberg 79312 ; GM 79312
• Manufacturer (Section G): N/A
• Manufacturer Contact: saschka busch ; im hausgruen 29; emmendingen, baden-württemberg 79312 ; GM 79312
• MDR Report Key: 23825740
• Report Number: 3004753785-2025-00003
• Device Sequence Number: 4993293
• Product Code: HAW
• UDI-Device Identifier: 04250307606184
• UDI-Public: 04250307606184
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K003486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: Health Professional
• Device Model Number: 803364
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown