MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 7.0 MM DIAMETER; ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE

Catalog Number	00222800700
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the reamer was fractured during a procedure.Attempts have been made an no further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - drill.Visual examination of the returned product identified the reamer was returned with the head detached from the flex shaft.Witness marks are seen at the distal end of the shaft.There is no epoxy residue and the distal end of the shaft.Measured the shaft diameter of the flex shaft and it is conforming to the print specification.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed as product was returned.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: b1, b2, b5, h1, h6 the following sections were updated: b4, g3, g6, h2, h11 once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the tip of the pressure sentinel reamer disassembled during usage and was retained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h11 the following sections were corrected: h6 ( investigation findings) a definitive root cause cannot be determined.The reported event is confirmed as product was returned.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: FLEXIBLE REAMER 7.0 MM DIAMETER
• Common Device Name: ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE
• 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: 21267926
• Report Number: 0001822565-2025-00204
• Device Sequence Number: 11651611
• Product Code: HWE
• UDI-Device Identifier: 00889024038752
• UDI-Public: (01)00889024038752(10)64533818
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00222800700
• Device Lot Number: 64533818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 07/29/2025; 08/20/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/08/2025; 08/15/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 470MM MOD REAMER HUDSN CAT# (B)(4). LOT# H83AA4.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 77 KG