MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; STERNAL TALON

Model Number	24-009-14-71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that the talon was found broken during a revision surgery due to patient condition, sternal non-union.The talon was removed and replaced with sternal plating.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Additional Manufacturer Narrative
Lot number identified.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: STERNAL TALON
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8496396
• Report Number: 9610905-2019-00112
• Device Sequence Number: 13718812
• Product Code: HRS
• UDI-Device Identifier: 00888118031099
• UDI-Public: (01)00888118031099
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2019
• Report Date (Section F): 03/28/2019

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: 24-009-14-71
• Device Lot Number: 31737211
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 08/06/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/21/2019; 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR