MAUDE Adverse Event Report: EXACTECH, INC. RESURFACING REAMER, 50MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	313-25-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this surgeon was in the process of reaming the humeral bone to prepare it for resurfacing, when the outer cutter ring of the reamer broke into two pieces.The majority of the reamer remained attached to the modular reamer handle and the dissociated piece fell onto the or floor.There was no delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the broken reamer reported was likely the result of off-axis reaming, which led to crack initiation, propagation, and ultimate failure of the reamer blades.Section h11: *the following sections have corrected information: (h6) component code: 777, cutter/blade.

• Brand Name: RESURFACING REAMER, 50MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16333830
• Report Number: 1038671-2023-00130
• Device Sequence Number: 20544452
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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: 313-25-50
• Device Lot Number: 56478005
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 09/01/2026
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/17/2023; 09/01/2026
• 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 Age: 60 YR
• Patient Sex: Male