MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH &CO. KG TELIX K; 209-010-0502

Model Number	209-010-0502
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the hospital, that both available set instruments from the telix k system jammed after the trials were inserted.After several attempts the instrument could be loosened from the trial and used to place the implant.The insertion of the implant worked without a problem.

• Brand Name: TELIX K
• Common Device Name: 209-010-0502
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH &CO. KG; bertha-von suttner str. 23; villingen-schwenningen, 78054 ; GM 78054
• Manufacturer Contact: gerd federle ; bertha-von-suttner strasse 23; villingen-schwenningen 78054 ; GM 78054
• MDR Report Key: 14641313
• Report Number: 8010944-2022-00002
• Device Sequence Number: 19986869
• Product Code: LXH
• UDI-Device Identifier: 04250869633314
• UDI-Public: 04250869633314
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 209-010-0502
• Device Catalogue Number: 209-010-0502
• Device Lot Number: BDM4WTG / BDM86TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White