MAUDE Adverse Event Report: EXACTECH, INC. INSERTER, SMALL GLENOID PLATE, SPRING-LOADED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-35-23
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgical use, the pin fell out and was disassembled.No parts or pieces fell into the patient wound site.No surgical delay/prolongation.No patient information provided.Device is returning.
Additional Manufacturer Narrative
(h3): pending evaluation.
Additional Manufacturer Narrative
The broken small glenoid baseplate inserter reported may have been due to the device being subjected to repeat forces over numerous surgical uses, which led to failure of the weld holding the dowel pin onto the baseplate inserter, and ultimately resulted in disassembly of the subcomponents.

• Brand Name: INSERTER, SMALL GLENOID PLATE, SPRING-LOADED
• 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: 17595291
• Report Number: 1038671-2023-02003
• Device Sequence Number: 7420788
• Product Code: LXH
• UDI-Device Identifier: 10885862566355
• UDI-Public: 10885862566355
• Combination Product (Y/N): N
• 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): 05/13/2024

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: 321-35-23
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 05/13/2024
• 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 Sex: Unknown