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

Catalog Number	00249003200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impaction head fractured.No known patient consequences were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #: 00249001200; lot #: 64548404.Report source: foreign - event occurred in 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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 h6: component code - proposed code: mechanical (g04)- impactor visual examination of the provided photo identified the impactor has fractured at the threads.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of returned product identified the impactor has fractured at the threads.Wear and tear can be seen indicating repeated use.The root cause of the reported event remains unchanged; a definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: IMPACTION HEAD
• Common Device Name: INSTRUMENT, EXTREMITIES
• 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: 15834606
• Report Number: 0001822565-2022-03222
• Device Sequence Number: 5126699
• Product Code: LXH
• UDI-Device Identifier: 00889024063495
• UDI-Public: (01)00889024063495(10)64814278
• 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,Followup
• Report Date (Section B): 10/20/2023

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: 64814278
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 10/19/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/20/2022; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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: Unknown
• 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: Prefer Not To Disclose