MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACTION HEAD; INSTRUMENT/TRAUMA

Catalog Number	00249003200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported an impaction head fractured inside the targeting jig during a procedure.No foreign body retained and no harm to the patient have been reported.Attempts have been made and no further information is available.
Event or Problem Description
No additional information regarding this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4, b5, g3, h2, h3, h6.Corrected: d4(udi).Visual examination of the returned product and provided pictures identified that the threaded post is fractured and remains in the tibial targeting guide handle.The impactor shows wear and tear that indicates repeated use during potential field age greater than 5 years.Device history record (dhr) was reviewed, and no discrepancies were found.A definitive root cause could not be determined.It should be noted that upon additional review of this device malfunction, there has not been a report for serious injury or adverse event due to fracturing of this device.Zimmer biomet considers this event nonreportable.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.

• Brand Name: IMPACTION HEAD
• Common Device Name: INSTRUMENT/TRAUMA
• 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: 16655216
• Report Number: 0001822565-2023-00858
• Device Sequence Number: 15083385
• Product Code: LXH
• UDI-Device Identifier: 00889024063495
• UDI-Public: (01)00889024063495(10)63849647
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00249003200
• Device Lot Number: 63849647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown