MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX 2 COIL

Model Number	1068226
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Pain (4836)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had pain on his leg from the pressure on the coil.The patient gets pain even from wearing pants.The leg is very sensitive to anything touching his left leg.The pain level was noted to be an 8 out of 10, especially when moving.The patient has to shave his leg because when the hair moves it is very painful.The patient is taking ibuprofen 800mg and tylenol.The patient had an appointment with their doctor on (b)(6) 2024.The sales representative was looking into switching the device as the patient does not think that he can wear the bone healing system (bhs) device anymore.It was later reported that the patient had not spoken to his doctor yet because the doctor was difficult to get a hold of.The patient continues to wear the device but stated it feels like it is breaking his leg.The patient believes the accident he was in may have misplaced muscles in his leg or caused soft tissue damage.The patient has not recently increased daily activities.He as actually decreased daily activities due to the pain.The patient stated he was going to contact the states represented about switching to a different device or stop wearing the unit.It was later reported that the patient was switched to an orthopak device due to sensitivity issues with his leg.
Additional Manufacturer Narrative
H2, h8, h3, h5: labeled for single use.Additional information in d4, g3, h6: component, investigation type, findings, and conclusions and h10: additional narrative.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 trend.
Event or Problem Description
It was reported that the patient had pain on his leg from the pressure on the coil.The patient gets pain even from wearing pants.The leg is very sensitive to anything touching his left leg.The pain level was noted to be an 8 out of 10, especially when moving.The patient has to shave his leg because when the hair moves it is very painful.The patient is taking ibuprofen 800mg and tylenol.The patient had an appointment with their doctor on (b)(6) 2024.The sales representative was looking into switching the device as the patient does not think that he can wear the bone healing system (bhs) device anymore.It was later reported that the patient had not spoken to his doctor yet because the doctor was difficult to get a hold of.The patient continues to wear the device but stated it feels like it is breaking his leg.The patient believes the accident he was in may have misplaced muscles in his leg or caused soft tissue damage.The patient has not recently increased daily activities.He as actually decreased daily activities due to the pain.The patient stated he was going to contact the states represented about switching to a different device or stop wearing the unit.It was later reported that the patient was switched to an orthopak device due to sensitivity issues with his leg.No additional patient consequences/ further information has been reported.The sflx 2 coil was not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX 2 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19423967
• Report Number: 0002242816-2024-00072
• Device Sequence Number: 15429971
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/09/2024

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: 1068226
• Device Catalogue Number: 1068226
• 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: 05/30/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic