MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT TIB TAMP GUIDE

Catalog Number	02-029-22-2000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, after the cleaning process was completed at the hospital, the button and spring had disengaged from the tibia tamp handle and the spring has been lost.There was no patient involvement reported.The handle and button will be returned.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event was likely the result of insufficient overlap between the snap ring and the lip of the housing to prevent the occurrence of disengagement.No information provided in the following section(s): a2, a3, a4, a5, b6, b7, d4 (serial number, exp date), g5, h4.The following section(s) have additional info: d10, g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Common Device Name: TRULIANT TIB TAMP GUIDE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10457642
• Report Number: 1038671-2020-00503
• Device Sequence Number: 4093136
• Product Code: LXH
• UDI-Device Identifier: 10885862523723
• UDI-Public: 10885862523723
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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 Catalogue Number: 02-029-22-2000
• Device Lot Number: 82388001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other