MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS INSERTER DRAW ROD, FLEX-THREAD; INSERTER ROD

Model Number	8439-1
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The draw rod had been inserted into the nail and was tightened appropriately by the surgeon during the case.According to the surgeon's narrative, he grabbed a t8 screwdriver to actuate the reduction device, but instead inadvertently continued actuating the draw rod.
Event or Problem Description
The event included the fracture of the tip of a draw rod.The fracture tip was left inside the driving feature of the nail, which was implanted in the patient.

• Brand Name: INSERTER DRAW ROD, FLEX-THREAD
• Common Device Name: INSERTER ROD
• Manufacturer (Section D): CONVENTUS FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• MDR Report Key: 12339194
• Report Number: 3009996260-2021-00012
• Device Sequence Number: 3602664
• Product Code: HSB
• UDI-Device Identifier: 00840118117555
• UDI-Public: 00840118117555
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K202858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 8439-1
• Device Catalogue Number: 8439-1
• Device Lot Number: 0000011091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/18/2021
• 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: 61 YR
• Patient Weight: 124