MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SELF DRILLING PIN 5 MM DIAMETER 200 MM LENGTH 80 MM; PROSTHESIS, ANKLE

Model Number	00-4501-040-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the initial procedure was performed with tm ankle system.Approximately four months post-procedure, while the patient was walking, they experienced a shock in the right leg and had a fracture of the tibial diaphysis where the pin was inserted.No revision has been reported to date.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00450104005, 64930381, self drilling pin 5 mm diameter 200 mm length 80 mm thread length.00830001400, 64532051, talar component size 4 left orange for use with size 4 tibial.Components only.00830005400, 64467037, tibial insert component size 4 orange plus (+) 0 mm thickness for use with size 4 talar components only for export only not for distribution in the u.00830004400, 64748825, tibial base component size 4 orange for use with size 4 talar.Components only.00450107600, 65159428, bur.00450104000, 64799291, calcaneus pin.00450104000, 64896804, calcaneus pin.00450104001, 63863518, kirschner wire style 6 1.6 mm (.062 inch) diameter.00450104004, 64208974, self drilling pin 4 mm diameter 150 mm length 40 mm thread length.00450106501, 64946034, protective sleeve sterile product do not resterilize.Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.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: 0001822565 - 2022 - 00694.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following reported event was confirmed by review of radiographs.Review of the available records identified the following: there is a mildly displaced fracture of the left tibial diaphysis.Operative change is present from prior ankle arthroplasty and lateral malleolar plate and screw fixation.The arthroplasty alignment is maintained and the distal plate and screws are intact.Bone quality appears mildly osteopenic.There is no radiographic evidence of trauma.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
Event or Problem Description
No additional event information is available at the time of this report.

• Brand Name: SELF DRILLING PIN 5 MM DIAMETER 200 MM LENGTH 80 MM
• Common Device Name: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13775451
• Report Number: 0001822565-2022-00695
• Device Sequence Number: 3824368
• Product Code: HSN
• UDI-Device Identifier: 00889024270459
• UDI-Public: (01)00889024270459(17)310607(10)65138646
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 00-4501-040-05
• Device Catalogue Number: 00450104005
• Device Lot Number: 65138646
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown