MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRESSURE SENTINEL FLEXIBLE REAMER 8.0 MM DIAMETER; INSTRUMENT/TRAUMA

Catalog Number	00222800800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon was using the instrument it fractured.There was no foreign body retained or harm to the patient.
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.H3: 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated:.The following sections were corrected:.Component codes: mechanical (g04) - drill visual examination of the returned product identified signs of use and wear and tear.The a/o connection feature of the reamer has some gouges and scratches.The shaft of the reamer has galling and the reamer tip has rolled and cracked material.The shaft of the reamer has fractured and a portion of the shaft remains inside the reamer tip.Measured the shaft diameter and it was conforming.The overall length of the device could not be measured due to the fracture and the diameter of the reamer tip could not be measured due to the damage of the tip.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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: PRESSURE SENTINEL FLEXIBLE REAMER 8.0 MM DIAMETER
• 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: 21457975
• Report Number: 0001822565-2025-00462
• Device Sequence Number: 7854792
• Product Code: HWE
• UDI-Device Identifier: 00889024038776
• UDI-Public: (01)00889024038776(10)65239981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/12/2025

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: 00222800800
• Device Lot Number: 65239981
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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