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

Model Number	00-2490-032-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: south africa.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
It was reported that the threaded tip of the instrument fractured when the surgeon attempted to implant the implant into the patient.No pieces fell into the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.H6: component codes: mechanical(g04)- impactor.Visual examination of the provided picture identified the threaded tip of the impaction head has fractured and was then retained in the targeting handle.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not 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: 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: 15833827
• Report Number: 0001822565-2022-03191
• Device Sequence Number: 5126679
• Product Code: LXH
• UDI-Device Identifier: 00889024063495
• UDI-Public: (01)00889024063495(10)64487974
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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 Model Number: 00-2490-032-00
• Device Catalogue Number: 00249003200
• Device Lot Number: 64487974
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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: 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
• Patient Sex: Unknown