MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX 1 COIL

Model Number	1068225
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient felt some pain and heat.The doctor took the cast off and there was a blister.The doctor advised not to treat for a few days.Later the patient indicated that they felt numbness and heat- "like their hand is on fire" which was associated with pain level of 8-9 on a scale of 1-10, 10 being the worst.They felt the pain for 20-30sec and removed the device.The patient contacted their doctor who advised to stop using the unit for few days and try is again.The patient started using the device now but he is still feeling numbness and tingling in his right hand after few hours of treatment, no pain or burning sensation.The doctor did not prescribe any medications.No further consequences were reported.The sflx-1 coil was not returned for evaluations.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow up report will be sent.
Additional Manufacturer Narrative
Additional information in h4: manufacture date, g3, h6 and h10: additional narrative.B4: date of the event: estimated date of the event is november 2024.B4: date of the report.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.Without a product return, no product evaluation can be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported by the sales representative that the patient felt some pain and heat.The doctor took the cast off and there was a blister.The doctor advised not to treat for a few days.Later the patient indicated that they felt numbness and heat- "like their hand is on fire" which was associated with pain level of 8-9 on a scale of 1-10, 10 being the worst.They felt the pain for 20-30sec and removed the device.The patient contacted their doctor who advised to stop using the unit for few days and try is again.The patient started using the device now but he is still feeling numbness and tingling in his right hand after few hours of treatment, no pain or burning sensation.The doctor did not prescribe any medications.No further consequences were reported.The sflx-1 coil was not returned for evaluations.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX 1 COIL
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 20800096
• Report Number: 0002242816-2024-00157
• Device Sequence Number: 6832988
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P790002
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2025

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 Model Number: 1068225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic