MAUDE Adverse Event Report: TEDAN SURGICAL INNOVATIONS PHANTOM AL BLADE HOLDER

Model Number	AL-0105
Medical Device Problem Codes	Break (1069); Crack (1135); Material Fragmentation (1261); Detachment of Device or Device Component (2907); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the case, the pivoting blade holder tab broke.Two of the blade holder tabs snapped while tightening the retractor blade and flew out of the sterile field.Subsequently, another two blade holder tabs snapped during rest position, even without any ongoing tightening.There was no patient or user harm that occurred in this incident.However, these incidents pose potential safety risks to both the medical team and the patient per the healthcare professional in the surgical operation.
Additional Manufacturer Narrative
Device has not been returned.
Additional Manufacturer Narrative
The deformation observed at the failure points is consistent with the material failure characteristics seen in locking screw components intentionally brought to failure during internal design testing.The investigation determined that the issue is consistent with the application of force exceeding the intended design limits of the system.Excessive force may occur through over-torquing (greater than 159 in-lbs [17.9 nm]) or the application of excessive leverage using the al-0106 driver handle (greater than 57.8 lbf [257.1 n]).The al-0105 bolts are designed to provide a minimum retraction holding force of 10 lb [44.5 n].Internal specification requirements requires approximately 40 in-lbs [4.5 nm] of applied torque to achieve this holding force.Application of force beyond these limits, whether during a single use or cumulatively over multiple uses, can result in deformation and reduced mechanical strength of the locking screw bolts.Under elevated clamp loads, a damaged bolt may fail unexpectedly.As reported from point of contact, failure occurred to all returned units during one single case.Units are from 3 separate lots and have been in use for a minimum of three years.Multiple lot failure with identical failure modes, occurring during one surgical case indicates excessive force stemming from user error.
Event or Problem Description
During the case, the pivoting blade holder tab broke.Two of the blade holder tabs snapped while tightening the retractor blade and flew out of the sterile field.Subsequently, another two blade holder tabs snapped during rest position, even without any ongoing tightening.There was no patient or user harm that occurred in this incident.However, these incidents pose potential safety risks to both the medical team and the patient per the healthcare professional in the surgical operation.

• Brand Name: PHANTOM AL BLADE HOLDER
• Common Device Name: BLADE HOLDER
• Manufacturer (Section D): TEDAN SURGICAL INNOVATIONS; 12320 cardinal meadow dr; suite 150; sugarland TX 77478 6237
• Manufacturer (Section G): WEST COAST SURGICAL; 10727 kinghurst dr; houston TX 77099 3509
• Manufacturer Contact: anita davies ; 12320 cardinal meadow dr; suite 150; sugarland, TX 77478-6237 ; 7137260886
• MDR Report Key: 23855791
• Report Number: 3005726885-2025-00001
• Device Sequence Number: 16049620
• Product Code: LXH
• UDI-Device Identifier: 00843059100952
• UDI-Public: (01)00843059100952(11)20190301(10)0319
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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 Model Number: AL-0105
• Device Lot Number: 0319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown