MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING DUAL COMPRESSION PLATE 14 HOLES 183 MM LENGTH; TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-(b)(4).G2: china.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : will not be returned.
Event or Problem Description
It was reported that the patient had a revision on an unknown date due to a plate fracture.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed through radiograph review.Radiographs identified the following: four views of the right humerus demonstrate a plate and screw fixation device traversing a comminuted fracture of the mid diaphysis.Final two images demonstrate fractured plate along the mid aspect of the level of the fracture site.Incomplete healing of a comminuted fracture of the mid diaphysis likely led to the hardware failure.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the case information by a health care professional indicated the standard of care for this type of fracture would be a 4.5mm plate, but a 3.5mm plate was used in this case.However, with the information provided a definitive root cause cannot 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.

• Brand Name: 3.5 MM LOCKING DUAL COMPRESSION PLATE 14 HOLES 183 MM LENGTH
• Common Device Name: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17342236
• Report Number: 0001822565-2023-01902
• Device Sequence Number: 6523959
• Product Code: HRS
• UDI-Device Identifier: 00889024104297
• UDI-Public: (01)00889024104297(17)271031(10)63798284
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060710
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 47493601407
• Device Lot Number: 63798284
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown