MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX - XL COILETTE

Model Number	1068240
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Paresthesia (4421)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the lot # is unknown as the product was not returned for evaluation.H4: the device manufacture date cannot be provided as the lot number for the product is unknown.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.
Event or Problem Description
It was reported that the patient was complaining of pins and needles on the toes of her left foot and on her femur of the opposite leg.It was noted that the coil does not touch the patient¿s toes.It was later reported that the patient felt an electric shock the first time she used the stimulator on her left foot.The patient was experiencing pain and went to the orthopedist who recommended using the unit for 5 hours.The patient rated the pain as a 10 on a scale of 1-10, with 10 being the highest.The patient continued to feel a tingling sensation on the left foot and the pain comes and goes.It was later reported by the sales representative that the patient was treating with the sflx xl coilette.
Event or Problem Description
It was reported that the patient was complaining of pins and needles on the toes of her left foot and on her femur of the opposite leg.It was noted that the coil does not touch the patient¿s toes.It was later reported that the patient felt an electric shock the first time she used the stimulator on her left foot.The patient was experiencing pain and went to the orthopedist who recommended using the unit for 5 hours.The patient rated the pain as a 10 on a scale of 1-10, with 10 being the highest.The patient continued to feel a tingling sensation on the left foot and the pain comes and goes.It was later reported by the sales representative that the patient was treating with the sflx xl coilette.
Additional Manufacturer Narrative
D4: the lot # is unknown as the product was not returned for evaluation.H4: the device manufacture date cannot be provided as the lot number for the product is unknown.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.The device history record was reviewed, and no discrepancies related to the reported event were found.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: 0002242816-2024-00086.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX - XL COILETTE
• 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: 20602753
• Report Number: 0002242816-2024-00141
• Device Sequence Number: 7411054
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• 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): 11/03/2024

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: 1068240
• Device Catalogue Number: 1068240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic