MAUDE Adverse Event Report: EBI, LLC. SFLX 4 COIL

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Burning Sensation (2146); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2022.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient underwent orif and bone graft surgery to repair a distal fibula nonunion fracture.After surgery she began to treat with a bhs unit since she was in a cast for 6 weeks and the doctor wanted her on stimulator immediately post-op.The patient had a follow-up appointment with the doctor.She still has not healed.The doctor wants her to continue with a bone stimulator but wants her to switch to orthopak because the patient is unable to tolerate the bhs for many hours.The patient claims that she could only use bhs for 5-7 hours at a time then her foot would feel very hot like her "bone was cooking".She would take a break and continue a couple of hours later.The discomfort was burning and not painful, but if she had to assign a pain scale it would be a 4 or 5 under the skin.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Corrections - b4: date of this report added, d3: manufacturer address and email address, d4: udi, g1: contact office and manufacturer site, g6: report type additional information - d9: device available for evaluation and returned to manufacturer date, g3, h2, h3, h4: device manufacture date, h6: impact code, device code, method, results, h10: additional narrative, h11.The sflx 4 coil was received for evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 4 coil part no.1068235 with (b)(6).The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 4 coil was reviewed and there were no reports of non-conformances or deviations.The sflx 4 coil was tested and it operates as intended.Calibration information: all tests inspections were completed using tektronix oscilloscope id (b)(4) with calibration due on (b)(6) 2025; (b)(4) which does not require calibration.Test/inspections were completed by the quality department on (b)(6) 2024.The failure was not confirmed for the reported condition of "patient unable to tolerate the bhs unit.".The coil was tested and operates as intended.Review of complaint history identified (1) total complaints from ((b)(6) 2021) to ((b)(6) 2022) for pn (1068235) and events related to (hot).Keyword search criteria: (complaint code: medical: hot) the search could not be specified further because the main complaint was hot.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "hot".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.(b)(6) medical will continue to monitor for trends.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 the patient underwent orif and bone graft surgery to repair a distal fibula nonunion fracture.After surgery she began to treat with a bhs unit since she was in a cast for 6 weeks and the doctor wanted her on stimulator immediately post-op.The patient had a follow-up appointment with the doctor.She still has not healed.The doctor wants her to continue with a bone stimulator but wants her to switch to orthopak because the patient is unable to tolerate the bhs for many hours.The patient claims that she could only use bhs for 5-7 hours at a time then her foot would feel very hot like her "bone was cooking".She would take a break and continue a couple of hours later.The discomfort was burning and not painful, but if she had to assign a pain scale it would be a 4 or 5 under the skin.No additional patient consequences have been reported.

• Brand Name: SFLX 4 COIL
• Common Device Name: 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15205157
• Report Number: 0002242816-2022-00083
• Device Sequence Number: 2109396
• Product Code: LOF
• UDI-Device Identifier: 00812301020577
• UDI-Public: 00812301020577
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 1068235
• Device Lot Number: 22082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic