MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; LPI IMPACTOR HANDLE

Catalog Number	213-65-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, the surgeon hit on the lpi handle to impact and the handle broke in two pieces, one part in the hand & another part on the floor.There were no pieces that went inside the body.No consequence for the patient.The device will be returned.
Additional Manufacturer Narrative
(h3) the evaluation of the of the reported event found that the fractured lpi impactor handle reported in was likely the result of the inherent potential for such breakage in the design and being exposed to high impaction forces required during implant surgeries.
Additional Manufacturer Narrative
After further review of additional information received the following sections were updated: b5,g4 b5: review determined this event was reported incorrectly as a serious adverse event requiring intervention and is being corrected to product problem with the type of reportable event as a "malfunction" corrections made to the following: b1: corrected to product problem b2: corrected to n/a h1: corrected to malfunction.

• Brand Name: EXACTECH
• Common Device Name: LPI IMPACTOR HANDLE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 10874638
• Report Number: 1038671-2020-00624
• Device Sequence Number: 3949246
• Product Code: LXH
• UDI-Device Identifier: 10885862059895
• UDI-Public: 10885862059895
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 213-65-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 05/11/2022
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 02/11/2021; 05/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown