MAUDE Adverse Event Report: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X47,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5047S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
Postoperative ct revealed an avulsion fracture of the medial cortical bone at the insertion site of a locking screw with distal of the long gamma nail.Revision surgery is not planned at this time.
Event or Problem Description
Postoperative ct revealed an avulsion fracture of the medial cortical bone at the insertion site of a locking screw with distal of the long gamma nail.Revision surgery is not planned at this time.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event, patient¿s medical records as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X47,5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 12377661
• Report Number: 0009610622-2021-00672
• Device Sequence Number: 19127860
• Product Code: HSB
• UDI-Device Identifier: 04546540382351
• UDI-Public: 04546540382351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Model Number: 1896-5047S
• Device Catalogue Number: 18965047S
• Device Lot Number: K0D47F6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other