MAUDE Adverse Event Report: BIOMET MICROFIXATION TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp-(b)(4).Customer has indicated that the product is in process 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: 0001032347-2020-00231.Concomitant medical products: 2.0mm system l-plate 4 hole, right, long 1.0 mm, part# 01-9232, lot# 107650.Tms system high torque (ht) cross-drive screw, 5/pk 2.0mm x 5mm, part# 25-2005, lot# 225510.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported that the plate and screws were removed approximately seven weeks after implantation due to an infection of the lower part of the zygomatic bone.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The parts were returned for investigation.A visual inspection was conducted and the screws show signs of use and explantation.The dhr was reviewed and there were no non-conformance's found.There are no indications of manufacturing defects.This is the only complaint in regards to an infection for 25-2005 lot 225510.The most likely underlying cause of the infection could not 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
This follow-up report is being submitted to relay additional information.

• Brand Name: TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10055544
• Report Number: 0001032347-2020-00232
• Device Sequence Number: 11442717
• Product Code: JEY
• UDI-Device Identifier: 00841036089528
• UDI-Public: 00841036089528
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 25-2005
• Device Lot Number: 225510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Hospitalization; Required Intervention