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 Codes	Migration or Expulsion of Device (1395); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Facial Nerve Paralysis (1846); Feeding Problem (1850); Nerve Damage (1979); Pain (1994); Inadequate Pain Relief (2388); Difficulty Chewing (2670)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; 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: 0001032347-2020-00142, 0001032347-2020-00143, 0001032347-2020-00144, 0001032347-2020-00145, 0001032347-2020-00146, 0001032347-2020-00147, 0001032347-2020-00148, 0001032347-2020-00149, 0001032347-2020-00150, 0001032347-2020-00151, 0001032347-2020-00152.Concomitant medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 024930; tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 186680; tmj system right fossa component, small, part# 24-6562, lot# 284560; tmj system left fossa component, small, part# 24-6563, lot# 212970; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# unk; 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# unk; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# unk; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# unk; tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# unk; tmj system cross drive emergency fossa screw 2.3mm x 9mm, part# 99-6589, lot# unk; 2.7mm system emergency cross drive screw, 1/pkg 3.2x8mm, part# 99-9948, lot# unk.Initial reporter: patient.
Event or Problem Description
It was reported the patient has experienced multiple issues with her bilateral temporomandibular joint prostheses since implantation thirteen years ago.The patient reported symptoms and procedures including nerve damage, neuroma removal, x-rays, botox injections, ct scan, pain, difficulty chewing, difficulty eating and a planned revision.The patient reported the nerve damage occurred immediately after implantation which resulted in her being unable to blink her right eye or move her right eyebrow.The patient reported a neuroma was removed from the right side of her jaw seven years ago.The patient reported she had x-rays taken by a dentist and was informed that a screw on the right side is not intact.The patient reported receiving botox to her face approximately one year ago to treat pain, but stated that it did not provide relief and aggravated the pain further.The patient reported a ct scan was taken four months ago and revealed that two screws on the right side were not intact and were not stable.The patient reported she has excruciating pain, difficulty chewing, and difficulty eating.She stated due to the difficulty eating, she chokes on her food.Additionally, she reported there is discomfort on the left side which is aggravated by bad weather but the issues are not significant.The patient reported there is a revision planned to remove the implants on her right side, but the date is not yet set.
Event or Problem Description
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.The complaint is confirmed because of the additional follow up treatment reported.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database could not be reviewed for the screws involved in this case due to the lot numbers remaining unknown.There are no indications of manufacturing defects.The most likely underlying 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.

• 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: 9811070
• Report Number: 0001032347-2020-00146
• Device Sequence Number: 11439153
• Product Code: HWC
• UDI-Device Identifier: 00841036053635
• UDI-Public: 00841036053635
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability