MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; GEMINUS HOOK PLATE

Model Number	GEMINUS Hook Plate
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hook plate detached from the geminus plate as seen in fluoroscopy.Devices involved in this product complaint were not returned for analysis.Records regarding hook plate, hpe screw and geminus plate from the last three lots manufactured were reviewed.They were found to meet our specifications.No other product complaint associated with this type of failure mode, "hook plate detached after procedure completion" have taken place in the last 12 months.The root cause associated with this product complaint appears to be a combination of geminus plate not properly positioned and hpe screw not fully secured.There is no concern regarding product in the field or inventory belonging to the same hook plate and hpe screw lot number.No facts or evidences were found to classify this product complaint as design or manufacturing related.No information was given on what they did with the broken piece and/or revision of surgery.
Event or Problem Description
A surgeon will be revising this disassociated hook plate from the geminus plating system.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: GEMINUS HOOK PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• MDR Report Key: 10299814
• Report Number: 3006742481-2019-00004
• Device Sequence Number: 16316058
• Product Code: HRS
• UDI-Device Identifier: 00841506101514
• UDI-Public: 00841506101514
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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 Hook Plate
• Device Catalogue Number: GMN-HP
• 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: 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