MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.5MM LOCK PLATE T-SHAPE SMALL; TRAUMA IMPLANTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine x-ray it was found that the implanted plate had broken.The patient states there was no fall, injury, or violence which would have caused this fracture patient was revised approximately 2 months post implantation.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Report source: czech republic.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 131220418, lock screw 1.5x20mm, lot # rm869p catalog #: 131220416, lock screw 1.5x16mm, lot # rm282s catalog #: 131220420, lock screw 1.5x20mm, lot # rm692r catalog #: 131220522, non lock screw 1.5x22mm, lot # m12641 a reported event was confirmed as visual examination of the returned product identified the plate has been fractured into 2 pieces.There are also some nicks and gouges on the outside edge of the plate.Fracture surface analysis conducted showed that the lock plate sample fractured due to fatigue.Eds semi-quantitative elemental analysis of the lock plate sample showed that it was consistent with ti-6al-4v alloy, along with foreign elements such as carbon, oxygen, sodium, silicon, and calcium.The radiographs showed two views of the first carpal metacarpal joint demonstrate malleable plate and screw fixation device which appears to be fractured.Partial withdrawal of the trapezium screw.Incomplete bony fusion of the joint space.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01410, 0001825034-2023-01723, 0001825034-2023-01724, 0001825034-2023-01725.

• Brand Name: 1.5MM LOCK PLATE T-SHAPE SMALL
• Common Device Name: TRAUMA IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16263504
• Report Number: 0001825034-2023-00160
• Device Sequence Number: 14968976
• Product Code: HRS
• UDI-Device Identifier: 00887868013331
• UDI-Public: (01)00887868013331(17)211127(10)ZB7138106
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K081546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 131220157
• Device Lot Number: ZB7138106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG