MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical product: biomet microfixation high torque cross-drive screw, catalog #: 91-1511, lot #: unk; biomet microfixation high torque cross-drive screw, catalog # 91-1513, lot #: unk; oxford performance materials (opm) htr-pekk henriksen right maxilla zygoma orbital implant, catalog #: pk620898, lot #: 060818; oxford performance materials (opm) htr-pekk henriksen rtigh maxilla implant, catalog #: pk620905, lot #: 060818.Therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation; it remains implanted in the patient.The investigation without the known screw part numbers was completed: reported event was unable to be confirmed due to limited information received from the customer.The distributor reported that the patient developed an infection approximately one week post-operatively.The distributor also reported that the type of infection was unknown, the infection was treated with antibiotics, and there are no plans to revise.No product was returned as the product remains implanted.No inspections or testing could be performed.No x-rays, scans, pictures, or physicians reports were provided.No additional information was provided as to the type or cause of the infection.The implants in this complaint are provided unsterile and are meant to be sterilized by the facility upon reception of the product.Device history record (dhr) review was unable to be performed as the part numbers and lot numbers of the devices involved in the event are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Once the investigation has been completed again with the new screw part numbers, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00526 & 0001032347-2019-00216.
Event or Problem Description
It is reported the patient experienced an infection approximately one (1) week after implantation.The patient was treated with antibiotics and the infection resolved.There is no revision planned.There is no known history of infection at the facility.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00526-3 & 0001032347-2019-00216-1.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8501308
• Report Number: 0001032347-2019-00215
• Device Sequence Number: 11358882
• Product Code: JEY
• UDI-Device Identifier: 00841036053321
• UDI-Public: 00841036053321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 91-1515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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