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

Model Number	N/A
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
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: tall cam boot.Therapy date: unknown.The customer has indicated that the product is in progress of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00041.
Event or Problem Description
It was reported that the patient developed a burn from using the bone healing system (bhs).The patient wore the coil directly on the left foot for a fifth metatarsal injury.The patient wore the unit for ten hours a day during the night.When the patient began treating with the device, she did not experience any symptoms.The patient noticed a red mark below the joint of the fifth metatarsal of the left foot.The patient said that the more she wore the coil, the worse the red mark got.Eventually, the red mark developed into a blister.The patient applied a band aid to the blister and left it for about a week.When the patient took off the band aid she noticed that the blister had gotten progressively worse.The patient contacted her doctor and was advised to go to a wound clinic and to stop using the unit.The patient also stated that her fourth and fifth metatarsal would twitch while using the unit.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional and corrected information.The device was returned to zimmer biomet for evaluation.Evaluation of the returned product indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported event.No failure and/or fault condition was found or confirmed.The device history record was reviewed and no discrepancies related to the reported event 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.The following sections were updated: d11: medical product: biomet ebi bone healing system sflx xl coilette: catalog: #1068240, lot: #19270.D11: therapy date: unknown.H3: device evaluated by manufacturer updated to yes.H6: method code updated to 10: testing of actual/suspected device.H6: method code updated to 3331: analysis of production records.H6: results code updated to 213: no device problem found.H6: conclusions code updated to 4315: cause not established.The following sections were corrected: h6: device code updated to 1437: overheating of device.
Event or Problem Description
It was reported that the patient developed a burn from using the bone healing system (bhs).The patient wore the coil directly on the left foot for a fifth metatarsal injury.The patient wore the unit for ten hours a day during the night.When the patient began treating with the device, she did not experience any symptoms.The patient noticed a red mark below the joint of the fifth metatarsal of the left foot.The patient said that the more she wore the coil, the worse the red mark got.Eventually, the red mark developed into a blister.The patient applied a band aid to the blister and left it for about a week.When the patient took off the band aid she noticed that the blister had gotten progressively worse.The patient contacted her doctor and was advised to go to a wound clinic and to stop using the unit.The patient also stated that her fourth and fifth metatarsal would twitch while using the unit.The patient said that the bhs controller would get hot.It was reported that no further information is available.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: NON-INVASIVE, BONE GROWTH, STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 10010891
• Report Number: 0002242816-2020-00040
• Device Sequence Number: 2728403
• Product Code: LOF
• UDI-Device Identifier: 00812301020553
• UDI-Public: 00812301020553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P790002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068234
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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