MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 5.5 MM DIAMETER; INSTRUMENT, SURGICAL, ORTHOPEDIC

Model Number	2228-05-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the crown of a drill shaft instrument detached from the shaft intra-operatively.No patient impact or adverse events have been reported as a result of this malfunction.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: germany.Customer has indicated that the product is in the process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - drill.Visual examination of the returned product identified the reported item was returned.As returned, the reamer head was assembled and locked onto the flex shaft.Attempts to remove the head failed.A witness mark from the press fit can be seen on the flex shaft.The overall length of the reamer measures over specifications indicating the reamer head has migrated from its¿ intended position.The diameter of the shaft is conforming to print specification.The cutting edges exhibit wear & tear.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: FLEXIBLE REAMER 5.5 MM DIAMETER
• 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: 16477448
• Report Number: 0001822565-2023-00570
• Device Sequence Number: 18004134
• Product Code: HWE
• UDI-Device Identifier: 00889024038721
• UDI-Public: (01)00889024038721(10)64925669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: 2228-05-05
• Device Catalogue Number: 00222800505
• Device Lot Number: 64925669
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 03/03/2023; 05/26/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose