MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REAMER; INSTRUMENT, SURGICAL, ORTHOPEDIC

Catalog Number	00221801800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial procedure, the reamer head fractured while reaming the canal.The correct surgical technique was used.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in canada.The customer has indicated that the product is in the 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 that 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 updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h5; h6 h6: proposed annex g code: mechanical (g04) - drill the reported event is unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h4.The 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.If any further information is found 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 is available at the time of this report.
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; h2; h3; h6, h11.Visual examination of the returned product confirmed that the reamer shaft is fractured.The product shows signs of repeated use.Dimensional analysis of the product determined that the product, when measured, was conforming to print specifications.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.The root cause is unchanged.If any further information is found that 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 is available at the time of this report.

• Brand Name: PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REAMER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• 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: 19994292
• Report Number: 0001822565-2024-02674
• Device Sequence Number: 18257997
• Product Code: HWE
• UDI-Device Identifier: 00889024038974
• UDI-Public: (01)00889024038974(10)65162865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2025

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: 00221801800
• Device Lot Number: 65162865
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 04/25/2025; 09/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/17/2024; 05/19/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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