MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX 3 COIL

Model Number	1068229
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	09/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient¿s foot was very swollen and numb.Initially there was no pain.The patient stated that they had not done any extra activities.The patient also stated that the first day he put on the unit, he had on a pair of paints with 6 zippers, clips, and metal chains.When he took off his pants the pins and needles went away.It was later reported that the patient spoke with their doctor who advised to expect some swelling and pain but to continue treating.The patient stated the swelling had subsided but was now experiencing some pain.The patient wanted to continue treating because the doctor said to expect pain.No further information was provided.It was later reported that the patient's doctor told him to keep using the device even though he feels an electricity-like feeling running through his body even when the device is off.The patient stated that he sought a second opinion and that the doctor told him his surgery is all wrong and he would need another surgery to correct it.The patient has not used the device since the initial complaint and does not plan to resume treatment in the future.No further information was provided.
Additional Manufacturer Narrative
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.The device history record was unable to be reviewed as the lot number of the product is unknown.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 trends.Related manufacturer's report - mfr#0002242816-2024-00122.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX 3 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 21314496
• Report Number: 0002242816-2025-00026
• Device Sequence Number: 8243914
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• 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
• Report Date (Section B): 02/04/2025

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: 1068229
• Device Catalogue Number: 1068229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic