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 Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, when the surgeon inserted logic femoral trial to the femur using the lpi femoral impactor assembled this lpi impactor hand and a mallet, the impactor handle had been fractured into two pieces at the part where the blue colored plastic part was not supported by any metallic parts.Then when the final femoral component (implant) was inserted, the surgeon impacted the rest of the blue colored plastic part fixed to the metallic part by a mallet had the part been completely broken into 3 pieces.The operation time was extended by approx.10 min due to this incident, but the femoral component was seated to the femur without any problem.Device is to be returned.Update 03-june-2020: we answer the two questions: are we reading the experience report correctly.The surgeon used the lpi instrument and broke it in half, into two separate pieces.Then the surgeon continued to use the instrument while broken which it then broke it into 3 additional pieces? yes, that¿s right.Did any pieces fall into the wound site? no.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the fractured lpi impactor handle reported in (b)(4) 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.

• Brand Name: EXACTECH
• Common Device Name: LPI IMPACTOR HANDLE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10174196
• Report Number: 1038671-2020-00312
• Device Sequence Number: 2143506
• Product Code: LXH
• UDI-Device Identifier: 10885862059895
• UDI-Public: 10885862059895
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 213-65-00
• Device Lot Number: 49039003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other