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

Model Number	STEMLESS SPRING INSERTER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2023
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 stemless surgery, the stemless spring inserter dis-assembled.There was less than a 5 minute surgical delay with no patient impact as a result.The patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
H6: the broken stemless spring inserter reported may have been due to a dowel pin fracture, which resulted in disassembly of the device.However, this cannot be confirmed as the instrument was not available for evaluation.
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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: STEMLESS SPRING 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16508342
• Report Number: 1038671-2023-00398
• Device Sequence Number: 6919276
• Product Code: LXH
• UDI-Device Identifier: 10885862538697
• UDI-Public: 10885862538697
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: UNK
• 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
• Report Date (Section B): 01/22/2026

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 SPRING INSERTER
• Device Catalogue Number: 319-00-10
• Device Lot Number: 400281004
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 06/05/2023; 01/14/2026
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 06/21/2023; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown