MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; MDLR RV RMR 38MM PLT TIP

Catalog Number	321-25-38
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the pilot tip on the 38mm pilot tip reamer snapped off and became embedded in the glenoid.The surgeon may have been a little overzealous with the reamer, which caused it to break.Representative advised that the surgeon should remove the pilot tip but the surgeon stated that he was unable to, then on subsequent attempts to try and remove it he stated that he had actually pushed it further into the glenoid and there was no way he was getting it out.The pilot tip remains inside the patient.
Additional Manufacturer Narrative
Section h10: (h6) evaluation codes: 3165, 1069.(h3) based on investigation conducted under capa2017-12, it was determined that the user instruction was not adequate to inform the surgeon of the appropriate use of the reamer.The foreseeable misuse of the glenoid reamer could resut in fracture of the pilot tip.

• Brand Name: EXACTECH
• Common Device Name: MDLR RV RMR 38MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9152333
• Report Number: 1038671-2019-00480
• Device Sequence Number: 2852857
• Product Code: LXH
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 321-25-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 01/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention