MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; GEMINUS VOLAR DISTAL RADIUS PLATE

Model Number	GEMINUS Volar Distal Radius Plate, Wide, 4 Hole, Right
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient declined to follow post-surgical procedures going against the ifu which states "the patient should be informed about the importance of following the post-operative rehabilitation prescribed in order to fully understand the possible limitations in activities of daily living.The patient must be warned that failure to follow postoperative care instructions may cause the implant or treatment to fail." the patient did not follow those procedures and remained active within the 6 weeks post op period.All manufacturing and inspections were conducted within specification.The product was not returned for evaluation and current information is insufficient to permit a definitive conclusion as to say that this was a product issue.
Event or Problem Description
Doctor performed a geminus surgery on a (b)(6) male on the right wrist.When patient returned for 6 weeks follow up, x-ray imaging showed broken screws on the distal portion of the plate.Patient refused follow up protocols and remained active within the 6-week post-op period.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: GEMINUS VOLAR DISTAL RADIUS PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• MDR Report Key: 10299818
• Report Number: 3006742481-2019-00001
• Device Sequence Number: 689857
• Product Code: HRS
• UDI-Device Identifier: 00841506101675
• UDI-Public: (01)00841506101675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: GEMINUS Volar Distal Radius Plate, Wide, 4 Hole, Right
• Device Catalogue Number: GMN-RTW-4HL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/20/2020
• 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: 78 YR