MAUDE Adverse Event Report: AVALIGN-NEMCOMED DIVISION MONOBLOC FLEXIBLE REAMER 11.5 - STD - DD

Model Number	03.045.115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure, the monobloc reamer broke apart in the patient's left femur into 2 pieces resulting in the doctor having to take out the larger portion of the reamer with a pliers.There was a surgical delay of three (3) minutes due to the reported event.The procedure was successfully completed.This report is for one (1) monobloc flexible reamer 11.5 - std - dd this is report 1 of 1 for complaint pc-(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, d4 device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: corrected data: d3, g1.
Event or Problem Description
It was noted the procedure was delayed for five (5) minutes.The patient status was reported as stable.

• Brand Name: MONOBLOC FLEXIBLE REAMER 11.5 - STD - DD
• Common Device Name: REAMER
• Manufacturer (Section D): AVALIGN-NEMCOMED DIVISION; 8727 clinton park drive; fort wayne IN 46582
• Manufacturer (Section G): AVALIGN-NEMCOMED DIVISION; 8727 clinton park drive; fort wayne IN 46582
• Manufacturer Contact: renee imbody ; 8727 clinton park drive; fort wayne, IN 46582 ; 6103142063
• MDR Report Key: 12980813
• Report Number: 2939274-2021-07057
• Device Sequence Number: 11940987
• Product Code: HTO
• UDI-Device Identifier: 00190776152994
• UDI-Public: (01)00190776152994
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 11/13/2021

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: 03.045.115
• Device Catalogue Number: 03.045.115
• Device Lot Number: N169923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 01/18/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/10/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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