MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG TAP 5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE; TAP Ø5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE

Model Number	208-040-0409
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection confirmed the reported complaint.At the moment this is considered an isolated incident.The manufacturer will be informed of this complaint and the device will be shipped for further investigation.If additional information becomes available, a follow-up medwatch report will be submitted.
Event or Problem Description
It has been reported verbally that the subject device broke when tapping the thread in the sacrum.The tip of the subject device could not be removed and was left in the bone.Surgery was resumed and the implantation procedure was completed with no other reports of patient impacts.

• Brand Name: TAP 5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE
• Common Device Name: TAP Ø5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner-strasse 23; villingen-schwenningen, 78054 ; GM 78054
• MDR Report Key: 8713537
• Report Number: 3013248720-2019-00001
• Device Sequence Number: 14022081
• Product Code: NKB
• UDI-Device Identifier: 04250869634472
• UDI-Public: (01)04250869634472(10)BDM5TST
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019
• Report Date (Section F): 06/18/2019

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: No Information
• Device Model Number: 208-040-0409
• Device Catalogue Number: 208-040-0409
• Device Lot Number: BDM5TST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Date Report Sent to FDA: 06/18/2019