MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS, INC.; DOUBLE IJS-E, ASSEMBLY

Catalog Number	IJS-DBL-BPA
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the ijs-e system states the following: "improper placement, positioning, alignment or fixation of the ijs-e construct may result in unusual stress conditions which may lead to subsequent reduction in the service life of the components, construct failure, postoperative complications or ineffective treatment." "the device is not designed to withstand the stress of weight bearing, load bearing, or excessive physical activity.Device loosening or breakage may occur when the implant is subjected to excessive loading during soft tissue healing or delayed healing." although this cannot be confirmed at this time as this is the first known failure of its kind and the device was not available for return, the patient's weight may have stressed the construct to the point of failure after eight weeks of use.
Event or Problem Description
An implanted double ijs-e (internal joint stabilizer - elbow) broke at the base of the medial boom arm eight weeks following intial implantation, requiring revision surgery.

• Brand Name: SKELETAL DYNAMICS, INC.
• Common Device Name: DOUBLE IJS-E, ASSEMBLY
• 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: 19487746
• Report Number: 3006742481-2024-00010
• Device Sequence Number: 17919018
• Product Code: OZI
• UDI-Device Identifier: 00841506109138
• UDI-Public: 00841506109138
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K231447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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
• Device Catalogue Number: IJS-DBL-BPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/1993
• Initial Report FDA Received Date: 06/07/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White