MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; THREADED PEG, LOCKING, 2.3MM, TI

Catalog Number	TPLS-23XXX-TS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A 2.3mm locking threaded peg broke following implantation of a geminus volar distal radius plate.
Additional Manufacturer Narrative
This failure was brought to the attention of skeletal dynamics nine months after the explantation date.No information pertaining to patient behavior following initial implantation and prior to the break was able to be obtained, no images from the original case nor the explantation were provided, and the implant was not available for return.Therefore, at this time the investigation is necessarily limited to internal testing and review of records.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: THREADED PEG, LOCKING, 2.3MM, TI
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 19345202
• Report Number: 3006742481-2024-00009
• Device Sequence Number: 7069673
• Product Code: HWC
• UDI-Device Identifier: 00841506103440
• UDI-Public: 00841506103440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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 Catalogue Number: TPLS-23XXX-TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White