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	06/12/2020
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: 0001032347-2020-00294, 0001032347-2020-00295, 0001032347-2020-00296, 0001032347-2020-00297, 0001032347-2020-00299, 0001032347-2020-00300.Concomitant medical products: 2.0mm system plate double-y-shape, long, part# 01-9262, lot# 333920; 2.0mm system plate 4 hole plate, straight, medium, part# 01-9288, lot# 706750; tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 426950; tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 636840b; tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 493230; tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 653390b; tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2007, lot# 651770t.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 the patient had a suspected infection four (4) weeks following implantation of cmf devices and underwent a revision five (5) weeks following implantation of cmf devices.During the re-operation, the surgeon noted the infection was a tissue problem and not an effect of the plate.The patient¿s tissues were washed and the devices remain implanted.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The distributor provided invalid lot numbers for some of the concomitant medical products; these items have been re-submitted as unknown lot numbers while awaiting customer response.D11 ¿ medical products 2.0mm system plate double-y-shape, long, part# 01-9262, lot# 333920 2.0mm system plate 4 hole plate, straight, medium, part# 01-9288, lot# 706750 tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 426950 tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# ni tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# 493230 tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2005, lot# ni tms system high torque (ht) cross-drive screw, 5/pk, part# 25-2007, lot# ni the following fields were updated: b4 date of this report b5 describe event or problem d11 medical products g4 date received by manufacturer g7 type of report h2 follow up type h10 additional narratives/data.
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 considered to be confirmed because it was reported that post-operative intervention was required to preclude serious injury to the patient.These plates and screws were not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or visual evaluations could be conducted.The dhr was reviewed and no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 25-2005, lot# 493230.The most likely underlying cause of the infection could not be determined.There are no indications of manufacturing defects.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: 10253183
• Report Number: 0001032347-2020-00298
• Device Sequence Number: 689523
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020

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: 493230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/30/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/17/2020; 10/30/2020
• 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