MAUDE Adverse Event Report: TEDAN SURGICAL INNOVATIONS, INC. TSI; ACCESSORY ARM

Model Number	AL-0110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tsi continues to request information from distributor.
Event or Problem Description
It was reported to the distributor, that while the procedure was taking place, a screw broke into 2 while the arm was installed properly.One of the two parts "projected" and hit an or personnel in the head and fell (translated from french).
Additional Manufacturer Narrative
Tsi continues to request information from distributor.02 sept 2021: customer confirmed that they will not receive device back from hospital.No further information is available.
Event or Problem Description
It was reported to the distributor, that while the procedure was taking place, a screw broke into 2 while the arm was installed properly.One of the two parts "projected" and hit an or personnel in the head and fell (translated from french).

• Brand Name: TSI
• Common Device Name: ACCESSORY ARM
• Manufacturer (Section D): TEDAN SURGICAL INNOVATIONS, INC.; 12615 w. airport blvd.; suite 200; sugar land TX 77478
• MDR Report Key: 12137439
• Report Number: 3005726885-2021-00001
• Device Sequence Number: 17256943
• Product Code: FWZ
• UDI-Device Identifier: 00843059100983
• UDI-Public: 00843059100983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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-0110
• Device Catalogue Number: AL-0110
• Device Lot Number: 0618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1