MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Shock (2072); Blister (4537)

Event Type  Injury  

Event Description

It was reported that the patient felt a "shock" while using her bone stimulator.The patient stated that it happened once about 3 weeks ago.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The patient developed blister on the lateral side of her ankle.The blister were little and the patient put a (b)(6) on it.The doctor prescribed antibiotics, doxycycline hyclate 100mg, twice a day for 10 days.The patient was told to apply the antibiotic ointment on the area.The blister is healing right now.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Concomitant medical product:medical product: unknown, therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

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).B3: date of event: the event occurred sometime in (b)(6) 2021.B4: date of this report.D11: medical product: bone healing system.D11: physical therapy date: unknown.G4: date received by manufacturer.G7: type of report.H3: device evaluated by manufacturer: yes.H4: device manufacturer date.H6: device code 2993: adverse event without identified device or use problem.H6: investigation code 3331: analysis of production records.H6: investigation finding code 3221: no findings available.H6: results code 3221: no findings available.H6: conclusions code 4315: cause not established.

Event Description

It was reported that the patient felt a "shock" while using her bone stimulator.The patient stated that it happened once about 3 weeks ago.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The patient developed blister on the lateral side of her ankle.The blister were little 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 apply the antibiotic ointment on the area.The blister is healing right now.It was reported that no further information is available.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 12752715
• MDR Text Key: 282201475
• Report Number: 0002242816-2021-00191
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002
• 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,Followup
• Report Date: 02/16/2022

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: 1068234
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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