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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Shock (2072)

Event Type  Injury  

Event Description

It was reported by that the physician of the patient felt a "shock" while using her bone stimulator.The patient then saw a blister on the lateral side of her ankle.The patient stated that it happened once.There was a little blister, and the patient put a band-aid on it.The doctor prescribed antibiotics, doxycyclune hyclate 100mg, twice a day for 10 days.The patient was told to put antibiotic ointment on the area.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The blister is healing right now.No additional patient consequences were reported.The coil was later returned for evaluation.

Manufacturer Narrative

The device was returned to zimmer biomet for investigation.No physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint.The device operated/functioned as intended.The device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in october 2021.Medical product: bone healing system.Physical therapy date: unknown.Date received by manufacturer.Device evaluated by manufacturer: yes.(b)(4).Narratives/data.

Manufacturer Narrative

The device was returned to zimmer biomet for investigation.No physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint.The device operated/functioned as intended.The device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: bone healing system.Physical therapy date: unknown.Date received by manufacturer.Device evaluated by manufacturer: yes.(b)(4).

Event Description

It was reported by that the physician of the patient felt a "shock" while using her bone stimulator.The patient then saw a blister on the lateral side of her ankle.The patient stated that it happened once.There was a little blister, and the patient put a band-aid on it.The doctor prescribed antibiotics, doxycycline hyclate 100mg, twice a day for 10 days.The patient was told to put antibiotic ointment on the area.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The blister is healing right now.No additional patient consequences were reported.The coil was later returned for evaluation.

• Brand Name: SFLX 1 COIL
• Type of Device: BONE HEALING SYSTEM(COILS)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13431848
• MDR Text Key: 286131881
• Report Number: 0002242816-2022-00007
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002/S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068225
• Device Lot Number: 21158
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female