MAUDE Adverse Event Report: EXACTECH, INC. MDLR RVS RMR 38MM CNLTD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MDLR RVS RMR 38MM CNLTD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during a surgical procedure, a size 38 cannulated reamer broke.Fragments, parts or pieces fell into the patient wound site and were removed.There was a surgical delay, amount of time not reported.Adverse event as a result indicated ¿no¿, ¿there are no adverse events as a result as yet¿.Patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the broken device reported was likely the result of applying a counterclockwise resistance force to the instrument greater than yield strength of the material, which led to crack initiation, propagation, and ultimate failure.However, this cannot be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: b5, d8.
Event or Problem Description
There is nothing to return.The broken reamer was thrown in the sharps bin for disposal.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: d8, d9: device receipt; h6: the broken device reported was likely the result of applying a counter clockwise resistance force to the instrument greater than yield strength of the material, which led to crack initiation, propagation, and ultimate failure.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: MDLR RVS RMR 38MM CNLTD
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15777263
• Report Number: 1038671-2022-01444
• Device Sequence Number: 6601177
• Product Code: LXH
• UDI-Device Identifier: 10885862087805
• UDI-Public: 10885862087805
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/21/2026

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 Model Number: MDLR RVS RMR 38MM CNLTD
• Device Catalogue Number: 321-35-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 12/30/2022; 04/13/2023; 03/27/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/13/2023; 04/05/2023; 05/08/2023; 04/21/2026
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown