MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR BROACH SIZE 5; INSTRUMENT, HIPS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
The broken rasp occurred during an initial surgery.Surgical technique was utilized.No additional information was available.
Additional Manufacturer Narrative
(b)(4).G2: foreign country: italy.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the rasp broke during surgery.There was no reported adverse patient impact.Though requested, no additional information was provided.
Additional Manufacturer Narrative
H6: component code: mechanical (g04) -rasp product was returned and evaluated.Visual examination of the returned product identified that the rasp cutting teeth are dull and worn.The flat surface around the etch showed indentations from previous uses.Post was confirmed to be fractured away from the rasp, and fractured piece was returned.The post showed indentations and signs of previous use.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.The complaint was confirmed based on the returned, fractured device.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 is available at the time of this report.

• Brand Name: AVENIR BROACH SIZE 5
• Common Device Name: INSTRUMENT, HIPS
• 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: 19704230
• Report Number: 0001822565-2024-02297
• Device Sequence Number: 19746257
• Product Code: LZO
• UDI-Device Identifier: 00889024510159
• UDI-Public: (01)00889024510159(11)230511(10)65659694
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2024

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: N/A
• Device Catalogue Number: 574999050
• Device Lot Number: 65659694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 12/26/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/11/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown