MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS PUNCH INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	STEMLESS PUNCH INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that the surgeon attached the inserter to the size 2 stemless broach and went to back the broach out and the handle kept coming loose after further looking at the handle it was discovered that the handle had come apart.One small part from the top of the handle fell on the floor and the other parts of the handle were set on the back table.Surgeon still needed to remove the size 2 broach so he used the cage extraction instrument from the ergo anatomic tray.He attached it to the broach along with a small slap hammer and back the broach out which came out.He then proceeded to put in the final implant and run it though a range of motion.Then he repaired the sub scap and closed.Patient was last known to be in stable condition following the event.No part off pieces fell into the wound site.No images or x-rays available.Device was returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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: STEMLESS PUNCH INSERTER
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17984943
• Report Number: 1038671-2023-02584
• Device Sequence Number: 18212236
• Product Code: LXH
• UDI-Device Identifier: 10885862538789
• UDI-Public: 10885862538789
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/18/2026

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: STEMLESS PUNCH INSERTER
• Device Catalogue Number: 319-01-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 02/18/2026
• 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: 63 YR
• Patient Sex: Male