MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW 1.5X16MM; TRAUMA IMPLANTS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
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 radiograph, it was found that the implanted plate was fractured.The patient states there was no fall, injury, or violence which would have caused this fracture.The patient was revised approximately 2 months post implantation.Radiographic review further discovered that there was partial withdrawal of the trapezium screw in addition to the implant fracture and malunion.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 131220157, 1.5mm lock plate t-shape small, lot # zb7138106.G2: czech republic.H3: 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.H3 other text : will not be returned.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as 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.No product was returned or pictures provided of the screws; visual and dimensional evaluations could not be performed.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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: 0001825034-2023-01723, 0001825034-2023-01724, 0001825034-2023-01725.

• Brand Name: LOCK SCREW 1.5X16MM
• 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: 17199884
• Report Number: 0001825034-2023-01410
• Device Sequence Number: 20275669
• Product Code: HRS
• UDI-Device Identifier: 00887868013652
• UDI-Public: (01)00887868013652(11)220518(10)RM282S
• 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,Followup
• Report Date (Section B): 08/03/2023
• 2 Devices were Involved in the Event: 1 2

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: 131220416
• Device Lot Number: RM282S
• Was Device Available for Evaluation?: No
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 07/26/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/21/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 90 KG