MAUDE Adverse Event Report: EXACTECH, INC. SLAPHAMMER ADAPTER

Catalog Number 151-00-16

Device Problems Break (1069); Fracture (1260)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

When trying to extract the final implant, the tip of the instrument broke in the stem, making it impossible to extract the stem.Because of this the surgeon performed an osteotomy of the femur.

Manufacturer Narrative

The complaint device was received for analysis.The condition of being broken was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) markings on the slap hammer: disortho, 02/17, & 151-00-16.The returned device was used with a slap hammer for the removal of the femoral stem and metaphyseal segment with screw from complaint.The slap hammer adapter was attached to the curved femoral stem when the failure of the threaded tip occurred.The sheared surface appears consistent with applying force to the slap hammer adaptor off axis.This bending force most likely caused the threads of the slap hammer adaptor to break off and remain in the femoral stem.The device was remarked by disortho with this company's catalog number, disortho logo, and a date.Galling is also present on much of the device, which appears to be consistent with using metal tools to remove the device.The wear and galling on the device in not expected with respect to the intended use.21cfr 820.3 (w).21cfr 820.3 (w)states that: "remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use; this is a disortho device." the device investigation by this company has discovered that disortho(an ous country) stamped it with "disortho" and a date, this appears that this device was processed and renovated by disortho.Patient-related issues: as per the experience report, the patient had a diaphyseal and metaphyseal fracture of the femur due to a traffic accident.The first procedure made during the surgery was an osteosynthesis with a plate, cable and screws to achieve stabilization of the femur to allow the surgeon to place hip revision.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues the broken device reported was likely the result of applying excessive force to the slap hammer adapter off axis , eventually causing the threads of the slap hammer adapter to break off and remain in the curved femoral stem.According to the ifu (b)(4) rev.R, as part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Only qualified surgeons are to use these products: who are fully knowledgeable about all aspects of the surgical technique and use of these implants, have full knowledge about the system compatibility's, and must be fully trained to properly use the system and instrumentation.There is also the potential for surgical intervention/revision and unintended bone fractures.This device is used for treatment not diagnosis.Information has been requested about the event and patient, no new information was provided.

Event Description

It was reported from colombia that the patient was noted to be stable, but unable to walk as he cannot support his leg.The surgical time is noted to be 6 hours.This patient was involved in motor vehicle accident that initially required this extensive joint surgery.No additional information is available.

• Brand Name: SLAPHAMMER ADAPTER
• Type of Device: SLAPHAMMER ADAPTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6908123
• MDR Text Key: 87967017
• Report Number: 1038671-2017-00731
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/23/2019

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
• Device Operator: Physician
• Device Catalogue Number: 151-00-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SLAP HAMMER (CAT# 113-03-03)
• Patient Outcome(s): Required Intervention