MAUDE Adverse Event Report: EXACTECH, INC. STD FINISHING GUIDE 3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	STD FINISHING GUIDE 3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
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
As reported, during surgical use, the holding peg of the size 3 lpi 4 in 1 cutting guide broke off during extraction, a set of bone nibblers were used to retrieve the peg.Parts and pieces fell into the patient wound site.Surgeon removed all of the parts and pieces.There was more than 5 minute surgical delay/prolongation.Patient did not experience any adverse events as a result.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays/photos.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3and h6 have been updated accordingly.(h3 the broken pin reported was likely the result of a stress riser introduced to the pin during removal, which led to brittle fracture.The most probable root cause associated with the reported event of "broken - retreived from patient¿ is associated with a partial or full-thickness crack in the device materials.

• Brand Name: STD FINISHING GUIDE 3
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14838695
• Report Number: 1038671-2022-00724
• Device Sequence Number: 17303252
• Product Code: LXH
• UDI-Device Identifier: 10885862058669
• UDI-Public: 10885862058669
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2022

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: STD FINISHING GUIDE 3
• Device Catalogue Number: 213-50-03
• Device Lot Number: 13506003
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 12/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female