MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM SFLX 1 COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2020.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.
Event or Problem Description
It was reported by the patient's husband that the patient was experiencing a burning sensation and discoloration of the foot while using the bone healing system (bhs).The patient began to treat with the device on (b)(6) 2020.The constant burning sensation started on the left foot 4 days ago.The burning sensation is below the skin and it is painful.The burning sensation and pain increased while using the stimulator.The patient's rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient was non-weight bearing at this time.The patient's husband stated that the left foot was purple and is darker than the right foot.It was later reported that the physician advised the patient to discontinue using the bhs.It was reported that no further information is available.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in d4, d8-9, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.Investigation summary: the sflx 1 coil was received for evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 1 coil part no.1068225 with julian date 19347.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 1 coil was reviewed in the product information section and there were no reports of non-conformances or deviations.The failure was not confirmed for the reported condition of "burning sensation and discoloration of the foot".The coil was tested and operates as intended.Review of complaint history identified (0) total complaints from (oct 1, 2019) to (oct 1, 2020) for pn (1068225) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Highridge medical will continue to monitor for trend.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported by the sales rep that the patient's husband stated that she took a shower and the water touching her foot felt like a burning sensation.This foot is also a different color.The burning sensation started on the left foot and it is constant but it increases when using the stimulator.The burning sensation is below the skin and it is painful.The pain level is an eight.The pain level has remained about the same for 4 days but it increases when wearing the bhs unit.The patient is not weight bearing at this time.The patient's husband, raymond stated that the left foot is purple and it is also darker than the right foot.I told the patient's husband to stop using the stimulator and to contact the doctor.No additional patient consequences have been reported.The sfxl coil was not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX 1 COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; 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: 10762731
• Report Number: 0002242816-2020-00115
• Device Sequence Number: 14286361
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 1068225
• Device Lot Number: 19347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic