MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 8MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Facial Nerve Paralysis (1846); Nerve Damage (1979); Pain (1994); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00515, 0001032347-2020-00516, 0001032347-2020-00517, 0001032347-2020-00518, 0001032347-2020-00520, 0001032347-2020-00521, 0001032347-2020-00522.Medical products: tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 670470c.Tmj system left fossa component, small, part# 24-6563, lot# 726860a.Tmj system right narrow mandibular component 45mm / 6 hole, part# 01-6545, lot# 710700b.Tmj system right fossa component, large, part# 24-6564, lot# 602100b.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni.Occupation¿ patient.
Event or Problem Description
It was reported the patient has experienced multiple issues following implantation of bilateral temporomandibular joint implants three (3) years ago.Immediately following implantation, the patient developed bell¿s palsy on the right side and was informed by the surgeon that it was a possible reaction to the surgery.The patient has used a bite splint for three (3) years to align the bite.The patient had a root canal a couple months ago and the endodontist took cone beam imaging.Based on the imaging, the endodontist believes the device is rubbing the bone and that the splint increases the pain.The patient has an unspecified one (1) inch deformity in the jaw.The patient underwent a dry needling treatment one (1) year ago that did not provide adequate pain relief.The patient wishes to get a referral to a neurologist to see if a screw is potentially hitting a nerve.The patient is not interested in a revision surgery unless it would bring pain relief.No additional patient consequences have been reported.
Event or Problem Description
It was reported the patient has experienced multiple issues following implantation of bilateral temporomandibular joint implants three (3) years ago.Immediately following implantation, the patient developed bell¿s palsy on the right side and was informed by the surgeon that it was a possible reaction to the surgery.The patient has used a bite splint for three (3) years to align the bite.The patient had a root canal a couple months ago and the endodontist took cone beam imaging.Based on the imaging, the endodontist believes the device is rubbing the bone and that the splint increases the pain.The patient has an unspecified one (1) inch deformity in the jaw.The patient underwent a dry needling treatment one (1) year ago that did not provide adequate pain relief.The patient wishes to get a referral to a neurologist to see if a screw is potentially hitting a nerve.The patient is currently receiving botox shots in the jaw from their dentist in order to try to relax the muscles.The patient is not interested in a revision surgery unless it would bring pain relief.The patient has been told by an oral surgeon that the patient has experienced too much bone loss to undergo additional surgery.The patient will continue with maintenance from their pain management doctors and also experiment with hypnosis.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the screws involved in this case.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 8MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10689172
• Report Number: 0001032347-2020-00519
• Device Sequence Number: 16937496
• Product Code: HWC
• UDI-Device Identifier: 00841036053635
• UDI-Public: 00841036053635
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 03/17/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/24/2020; 03/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention