MAUDE Adverse Event Report: EXACTECH, INC. MDLR RV RMR STRT PLT TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-25-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that during surgical use the pin tip on the pilot tipped starter reamer (321-25-01) broke off the reamer and ended up in the patients wound.The surgeon finished the procedure and before closing used x-ray to locate the broken piece and remove it prior to closing the wound.The surgeon admitted that he may have contributed to the instrument breaking by leaning on it too hard when reaming.There was about a 10min delay to the procedure while locating and extracting the broken tip.No patient information available.No photos or x-rays provided.Product is returning.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of applying a bending moment or excessive force to the reamer during use, which led to brittle fracture of the pilot tip feature.However, this cannot be confirmed as the device was not returned for evaluation and images were not provided.

• Brand Name: MDLR RV RMR STRT PLT TIP
• 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: 17500223
• Report Number: 1038671-2023-01928
• Device Sequence Number: 2394961
• Product Code: LXH
• UDI-Device Identifier: 10885862087614
• UDI-Public: 10885862087614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 11/01/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 321-25-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown